Written and maintained by CASRAI Editorial Board
Last updated
General product information only, drawn from regulator and device-database records. It is not medical advice and does not describe how to use an instrument on a patient.
Short answer
A Gelpi retractor is a hand-operated, self-retaining surgical retractor: a reusable, one-piece instrument with two legs, hooked distal tips and a mechanism that holds the legs open. In the United States it sits under FDA product code GAD (“Retractor”), regulation 21 CFR 878.4800, Class I and exempt from 510(k) premarket notification.
Definition and scope
The GMDN term recorded for a Gelpi retractor in AccessGUDID, the FDA/NLM device identifier database, is “Self-retaining surgical retractor, reusable”. GMDN defines that term as a hand-operated, self-retaining, one-piece surgical instrument used to draw aside the margins of a wound or incision to allow access to tissues and organs during open surgery. It is not intended to retract the ribs and is not dedicated to ophthalmic surgery. It has two legs with distal hooked tips and a self-retaining mechanism that keeps the legs open.
“Self-retaining” is the feature that separates this family from hand-held retractors, which need a person to hold them. For the hand-held side, see the guide to what a surgical retractor is, and the guides on the Volkmann retractor and Langenbeck retractor.
How it is described in practice
Catalogue and database entries show how the name is used. Two examples, both checked on 2026-10-30:
- An AccessGUDID record (device identifier 00840314216540) is titled “Gelpi Retractor 3 1/2″ sharp”, lists FDA product code GAD, and records single use as “No” and sterilization prior to use as “Yes”, with moist heat or steam sterilization as the listed method.
- The Medecins Sans Frontieres (MSF) product catalogue lists “RETRACTOR, GELPI, with ball stops 17 cm” under the category “General surgery spreaders and retractors, reusable”.
Between them, these entries name the instrument, give a length (3 1/2 inch in one, 17 cm in the other), state a tip description (“sharp” in the first) and mention ball stops (in the second). Neither listing is a specification for every Gelpi retractor; manufacturers define their own patterns, and the manufacturer’s instructions for use govern reprocessing.
Regulatory classification
| Item | Recorded value | Source |
|---|---|---|
| FDA product code and name | GAD, “Retractor” | FDA product classification database; openFDA |
| Regulation | 21 CFR 878.4800, manual surgical instrument for general use | eCFR |
| Device class | Class I (general controls) | FDA product classification; openFDA |
| Premarket notification | 510(k) exempt, subject to the limitations in 21 CFR 878.9 | eCFR |
| Review panel | General and Plastic Surgery | FDA product classification |
| Reusable / sterilize before use | Single use: No; sterilization prior to use: Yes (for the cited record) | AccessGUDID |
21 CFR 878.4800 describes a manual surgical instrument for general use as a nonpowered, hand-held or hand-manipulated device, either reusable or disposable, intended for various general surgical procedures. The same section states that a surgical instrument with specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. So a retractor listed under GAD is a general-use instrument; a specialty retractor may sit under a different regulation.
Where it matters for labs, clinics and supply decisions
This checklist shows what a Gelpi retractor listing can be expected to state, based on the records cited on this page. It is for reading a listing, not for ranking products.
| Listing attribute | What the sources show |
|---|---|
| Name and type | “Gelpi retractor” with GMDN term “Self-retaining surgical retractor, reusable” |
| Length | Stated in the title of both example listings (3 1/2 inch; 17 cm) |
| Tip description | “Sharp” appears in the AccessGUDID example title |
| Ball stops | Named in the MSF example title |
| Reusable or single use | GUDID field: single use No; MSF category: reusable |
| Sterilization | GUDID field: sterilization prior to use Yes; method listed: moist heat or steam |
| Regulatory identity | Product code GAD; Class I; 510(k) exempt |
Because the instrument is reusable and the cited record requires sterilization before use, reprocessing is part of owning it. The device identifier lookup shows the listed method; the full cleaning and sterilization instructions come from the manufacturer. The CASRAI guide to retractor blades covers blade terminology, and the Alexis retractor guide covers a different retractor type for comparison.
Common misunderstandings
“Class I means it is unregulated.”
Class I devices remain subject to general controls. Exemption from 510(k) notification is subject to the limitations in 21 CFR 878.9.
“Self-retaining means it fits every procedure.”
The GMDN definition excludes rib retraction and ophthalmic surgery, and 21 CFR 878.4800 says specialty instruments are classified elsewhere.
“All Gelpi retractors are the same.”
The two example listings differ in length and in which details they name. Compare the manufacturer’s own listing or instructions for use for the unit in question.
FAQ
What is a Gelpi retractor?
A reusable, hand-operated, self-retaining surgical retractor with two legs, hooked distal tips and a mechanism that holds the legs open (GMDN definition via AccessGUDID).
What FDA class is a Gelpi retractor?
Under product code GAD and 21 CFR 878.4800 it is Class I and exempt from 510(k), subject to the limitations in 21 CFR 878.9.
Is a Gelpi retractor reusable?
The cited AccessGUDID record lists single use as “No” and requires sterilization before use; the MSF catalogue places it in a reusable category.
Sources
- eCFR, 21 CFR 878.4800, Manual surgical instrument for general use, checked 2026-10-30.
- FDA, Product Classification, code GAD, and openFDA device classification API, checked 2026-10-30.
- NLM, AccessGUDID record 00840314216540, checked 2026-10-30.
- Medecins Sans Frontieres, MSF product catalogue entry 14233, checked 2026-10-30.
