Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information only, not medical advice and not a procedure guide.
Short answer
A Cushing retractor is a name used in catalogues for a hand-held surgical retractor, and it is not an FDA device category. A listing called “Cushing” can therefore sit under the general retractor product code (GAD, 21 CFR 878.4800, Class I) or, if the device is self-retaining and made for neurosurgery, under a different code (GZT, 21 CFR 882.4800, Class II). The product code and description tell you which.
Definition and scope
A surgical retractor holds the edges of a wound or tissue apart so the surgical site can be reached. The general-purpose entry in the FDA regulations, 21 CFR 878.4800, covers manual surgical instruments for general use, described as nonpowered, hand-held or hand-manipulated devices, and names retractors among them. That regulation classifies the group as Class I (general controls), exempt from premarket notification subject to the limits in 878.9.
“Cushing” is an eponym used by catalogues and distributors. It does not appear in the regulation text, so FDA does not define a “Cushing retractor” as a class of device. For background on the device family, see what a surgical retractor is and the overview of neurosurgical instruments.
How the name is used in listings
The NLM AccessGUDID database holds device records submitted by labelers. One example record, device identifier 04057034105139, is titled “Retractor, Manual, acc. Cushing 24cm 14mm”. It carries FDA product code GAD (Retractor) and the GMDN term 45918, “Hand-held surgical retractor, reusable”, which is defined as a hand-held, non-self-retaining device that separates wound margins for access in open surgery. The record shows the device as not sterile as packaged and as not requiring sterilization before use. It is one labeler’s record and does not define the name for every manufacturer.
Listings from different sellers can use “Cushing” for differently shaped instruments, so the description and the product code are more reliable than the name alone.
Hand-held versus self-retaining, and the FDA codes
The distinction that matters for classification is whether the retractor holds itself in place. FDA’s rule for neurosurgery, 21 CFR 882.4800, describes a self-retaining retractor for neurosurgery as a self-locking device used to hold the edges of a wound open during neurosurgery, and classifies it as Class II (performance standards). FDA’s classification database lists this as product code GZT, “Retractor, self-retaining, for neurosurgery”, Class 2, Neurology panel, 510(k) required, third-party review eligible (FDA product classification).
| Point | General hand-held retractor | Self-retaining retractor for neurosurgery |
|---|---|---|
| FDA product code | GAD | GZT |
| Regulation | 21 CFR 878.4800 | 21 CFR 882.4800 |
| Class | Class I, general controls | Class II (performance standards) |
| Premarket notification | Exempt, subject to 878.9 | 510(k) listed in FDA classification database |
A named hand-held instrument is not a self-retaining one, so a Cushing-named listing that is described as hand-held falls on the left side of the table. For related designs, see the cerebellar retractor and the malleable retractor.
Where it matters for labs, clinics and supply decisions
A short checklist, built only from the fields the sources above show:
- Description: does it say hand-held or self-retaining? The two sit in different regulations.
- Product code: GAD points to the general retractor entry; GZT points to the neurosurgical self-retaining entry.
- Reusable or single use: the GUDID example above is reusable.
- Sterile status as packaged: the GUDID example is not sterile as packaged and does not require sterilization before use. Always follow the manufacturer’s instructions for use.
- Tip and blade type: the name does not fix it, so read the description. See retractor blades for how blade types are described.
Common misunderstandings
Is “Cushing retractor” a regulated device name?
No. The regulation text uses functional descriptions such as “manual surgical instrument for general use” and “self-retaining retractor for neurosurgery”, not eponyms.
Does a neurosurgical use make it Class II?
Not by itself. The Class II neurosurgical entry is for self-retaining retractors. The general instrument regulation, 21 CFR 878.4800, covers hand-held, non-self-retaining devices, so the hand-held versus self-retaining description is what separates the two entries.
Do all listings with the name describe the same instrument?
No. Check each listing’s own description and product code.
FAQ
What is a Cushing retractor?
A catalogue name for a hand-held surgical retractor. The name is not an FDA category.
What FDA class is a Cushing retractor?
It depends on how the device is filed. A hand-held retractor under GAD and 21 CFR 878.4800 is Class I; a self-retaining neurosurgical retractor under GZT and 21 CFR 882.4800 is Class II.
Is a Cushing retractor reusable?
The AccessGUDID example record is reusable and not sterile as packaged. Other listings may differ, so read each one.
Sources
All checked 2026-10-31.
- 21 CFR 878.4800, Manual surgical instrument for general use: https://www.law.cornell.edu/cfr/text/21/878.4800
- 21 CFR 882.4800, Self-retaining retractor for neurosurgery: https://www.law.cornell.edu/cfr/text/21/882.4800
- FDA product classification database, code GZT: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=GZT
- NLM AccessGUDID, device identifier 04057034105139: https://accessgudid.nlm.nih.gov/devices/04057034105139
