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General product and regulatory information for lab, clinic and supply staff. It is not medical advice and does not describe how to use any instrument in surgery.
Short answer
A cerebellar retractor is a surgical retractor that manufacturers label with the word “cerebellar” in the product name or description. FDA has no device category with that name. In FDA records, devices described this way sit under several different product codes and classes, so the name alone does not tell you the regulatory status of a given instrument.
Definition and scope
A retractor is a hand instrument that holds tissue aside; the general idea is covered in what a surgical retractor is. “Cerebellar retractor” is a catalog and product-description term, not a defined regulatory term. FDA’s device classification database has no retractor listing with “cerebellar” in its device name; the only classification name containing the word is an implanted cerebellar stimulator, an unrelated implant (product code GZA, Class 3).
What FDA does define is the category a retractor falls into:
- Self-retaining retractor for neurosurgery (21 CFR 882.4800): “a self-locking device used to hold the edges of a wound open during neurosurgery.” Class II (performance standards). Product code GZT.
- Manual surgical instrument for general use (21 CFR 878.4800): a nonpowered, hand-held device for general surgical procedures; the regulation lists “retractor” among its examples. Class I (general controls), exempt from premarket notification subject to the limits in 21 CFR 878.9. Retractor product code GAD.
The same regulation adds that a surgical instrument with specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. That sentence is why a neurosurgical retractor and a general retractor can have different classes.
How FDA records label devices called “cerebellar”
FDA’s Global Unique Device Identification Database (GUDID) holds the labeler-submitted description of each device version. Searching the openFDA UDI endpoint on 2026-10-30 for the word “cerebellar” in the device description returned 177 records, spread over twelve product codes. The six largest are below; the count includes any device whose description contains the word, such as drill-set accessories, not only retractors.
| Product code | FDA device name | Class | Regulation | GUDID records with “cerebellar” |
|---|---|---|---|---|
| GAD | Retractor | 1 | 21 CFR 878.4800 | 118 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 2 | 21 CFR 882.4800 | 22 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 2 | 21 CFR 882.4300 | 13 |
| FFO | Retractor, Self-Retaining | 1 | 21 CFR 876.4730 | 8 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 21 CFR 888.4540 | 7 |
| HAO | Instrument, Surgical, Non-Powered | 1 | 21 CFR 882.4535 | 1 |
Source: openFDA device classification and UDI endpoints, classification data last updated 2026-10-19, checked 2026-10-30. The remaining records fall under six other codes.
Examples as listed in GUDID
These labeled records show how the same kind of name is filed. They are not endorsements or recommendations.
| Labeler and description (as listed) | Product code | Rx flag | Single-use flag | Published |
|---|---|---|---|---|
| Ambler Surgical: Adson self-retaining cerebellar retractor, 7 1/2″, straight, 4×4 sharp prongs, ring handle with ratchet | GZT (Class II) | Yes | No | 2016-09-29 |
| Avalign Technologies: Adson Cerebellar Retractor | GAD (Class I) | Yes | No | 2023-05-09 |
| Life Instrument Corporation: Cerebellar Retractor 90 deg. blunt tips | GAD (Class I) | No | No | 2021-10-04 |
| Surgical Direct: 6 1/2″ Adson Cerebellar Retractor, Angled 80 Degrees, 4 x 4 Sharp Prongs | FFO (Class I) | No | No | 2024-05-23 |
Adson-named cerebellar instruments appear under GZT, GAD and FFO. Each of the four records states that the labeling does not contain MRI Safety Information. Across all 177 records, 169 carry a not-single-use flag and 8 a single-use flag; 97 carry the prescription-use flag and 80 do not.
How the classification and listing data are used in practice
The product code, class and regulation number link an instrument to its FDA requirements. Class I devices under 21 CFR 878.4800 are subject to general controls and exempt from premarket notification within the limits of 21 CFR 878.9; Class II devices such as those under 21 CFR 882.4800 are subject to performance standards. Adverse-event handling for a marketed device falls under Medical Device Reporting, and the statutory origin of the class system is the Medical Device Amendments of 1976. Manufacturers also appear in the FDA registration and listing database.
Where it matters for labs, clinics and supply decisions
A checklist built only from the fields in the records above, for reading a device listing or supplier document:
- Product code and regulation number. Confirm the code the labeler filed rather than inferring it from the product name. Adson-named cerebellar instruments appear under GZT, GAD and FFO.
- Class. The class follows from the code: Class I for GAD, FFO, LXH and HAO, Class II for GZT and HBG.
- Single-use or reusable flag. GUDID carries a single-use field for each device version.
- Prescription flag. GUDID carries a prescription-use field; the examples above differ on it for similar names.
- MRI safety statement. All four examples state that labeling does not contain MRI Safety Information.
- Instructions for use. The labeler’s own instructions for use are the document for that specific product. Request them from the labeler or supplier.
Common misunderstandings
- “Cerebellar” is not a class. It is a descriptor in a product name; the class comes from the product code.
- One name does not mean one code. Similar Adson-style listings are filed as Class I general retractors and as Class II neurosurgical retractors.
- A word match is not a retractor match. Some GUDID records containing “cerebellar” are drill-set accessories (code HBG, for instance).
- A GUDID record is not an FDA endorsement. The record is labeler-submitted, and openFDA states its data is unvalidated and not for medical decisions.
FAQ
Is a cerebellar retractor a Class I or Class II device?
It depends on the product code the labeler filed. Records described as cerebellar retractors appear under GAD (Class I) and GZT (Class II), among others, as of 2026-10-30.
Does FDA define the term “cerebellar retractor”?
No. The classification database has no retractor entry using the word; FDA defines the self-retaining neurosurgical retractor (21 CFR 882.4800) and the general manual retractor (21 CFR 878.4800).
Is this page medical advice?
No. It summarizes public regulatory records and does not cover indications or surgical technique.
Sources
- 21 CFR 882.4800, Self-retaining retractor for neurosurgery: law.cornell.edu/cfr/text/21/882.4800 (checked 2026-10-30).
- 21 CFR 878.4800, Manual surgical instrument for general use: law.cornell.edu/cfr/text/21/878.4800 (checked 2026-10-30).
- openFDA device classification API, product codes GZT, GAD, HBG, FFO, LXH, HAO, GZA: api.fda.gov/device/classification.json (data updated 2026-10-19, checked 2026-10-30).
- openFDA device UDI API (GUDID records): api.fda.gov/device/udi.json (queried 2026-10-30).
