Deaver Retractor: FDA Class, Sterility and How to Read a Listing

General product and regulatory information only; this page is not medical advice and does not describe surgical technique.

Short answer

A Deaver retractor is a metal surgical retractor whose blade separates the margins of a wound or incision during surgery. In FDA’s database, retractors of this kind fall under product code GAD, 21 CFR 878.4800, Class I, and the records for Deaver blades describe them as reusable and supplied non-sterile, so they need sterilization before use.

Definition and scope

“Deaver” is a style name used by manufacturers in product names, for example “Symmetry® Retractor, Deaver, No 5” from Aspen Surgical Products and “Pro Deaver Retractor Blade” from KOROS U.S.A. Both appear in the National Library of Medicine’s AccessGUDID database under product code GAD (retractor) and GMDN term 46774, “Surgical retractor/retraction system blade, reusable”.

The GMDN definition of that term describes a distal component of a retraction system or retractor “designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure”. It may be attached to the frame of a retraction system or fixed onto a retractor handle, and the term itself does not include a handle. For the wider family of hand-held and self-retaining retractors, see what a surgical retractor is.

How it is described in device records

Two AccessGUDID records, one from Aspen Surgical Products and one from KOROS U.S.A., show what a listing typically tells a buyer or a sterile-processing team:

• Both are labelled reusable, not packaged as sterile, and “requires sterilization prior to use: Yes” (AccessGUDID).
• Both carry product code GAD and GMDN 46774.
• The Aspen record identifies the item by style and number (“Deaver, No 5”, catalog 50-4308) and lists no device sizes.
• The KOROS record gives its size in the description as “1-1/2 x 4-1/2 inches” while the structured size field reads “9x12mm”, so the description and the size field do not match in unit or in apparent dimensions.

Types and related concepts

The table sets the FDA classification entries side by side. Every row comes from FDA’s Product Classification database (checked 2026-10-30).

Product code	FDA device name	Regulation	Class	Review panel
GAD	Retractor	21 CFR 878.4800 (manual surgical instrument for general use)	1	General and Plastic Surgery
GZT	Retractor, self-retaining, for neurosurgery	21 CFR 882.4800	2	Neurology

The Deaver records cited above sit under GAD, not GZT. GZT is a separate product code for self-retaining retractors used in neurosurgery and carries a higher class. Blade-style parts are covered in retractor blades; other named styles include the Balfour retractor, the Gelpi retractor and the Langenbeck retractor.

Where it matters for labs, clinics and supply decisions

Reading a Deaver retractor listing: a checklist

Each point below traces to the device records or FDA entries above.

1. Product code. Confirm the record uses GAD (Class I, general-use manual instrument) rather than a code with a different class, such as GZT.
2. Reusable or single-use. The GMDN term for these blades is “reusable”; the record’s single-use field should agree with that.
3. Sterile status. Both records say the device is not packaged sterile and requires sterilization before use, so reprocessing is part of using it.
4. Blade only or with handle. The GMDN term excludes a handle; a blade may mount on a frame or fix onto a handle, so check what the listing actually includes.
5. Size. Compare the description with the structured size field, since the KOROS record shows them in different units and values.
6. Style numbering. “No 5” in the Aspen record is that manufacturer’s style number; the records do not establish a universal numbering across brands.

FDA notes that most Class I devices are exempt from 510(k) premarket notification, but the establishment must still register with FDA and the exemption has limits that manufacturers must confirm. GUDID pages themselves display no device class, so the class is read from the product-code entry, not from the listing.

Common misunderstandings

• “Deaver” is not an FDA device category. It is a style name; FDA classifies these items by product code (GAD).
• “Class I” does not mean no rules. The GAD entry shows the device is not exempt from good manufacturing practice (GMP exempt: No).
• Self-retaining is a different entry. A neurosurgical self-retaining retractor is classified separately (GZT, Class 2).
• Non-sterile is normal for these records. It means sterilization before use is required, not that the item is defective.

FAQ

What is a Deaver retractor?

A reusable metal retractor of the Deaver style whose blade separates the margins of a wound or incision during surgery. Manufacturers list it under names such as “Retractor, Deaver, No 5”.

What FDA class is a Deaver retractor?

The Deaver records cited above use product code GAD, which FDA lists as Class I under 21 CFR 878.4800 and exempt from 510(k).

Is a Deaver retractor supplied sterile?

The two AccessGUDID records cited (Aspen Symmetry and KOROS Pro-Retractor) say not packaged sterile and require sterilization prior to use. Other products may differ, so the individual record or instructions for use govern.

Is a Deaver retractor the same as a self-retaining retractor?

No. FDA classifies self-retaining retractors for neurosurgery separately under product code GZT, Class 2.

Sources

• AccessGUDID, Symmetry Deaver (DI 00887482017982), National Library of Medicine, checked 2026-10-30: accessgudid.nlm.nih.gov/devices/00887482017982
• AccessGUDID, Pro-Retractor Deaver Retractor Blade (DI 10840199542632), checked 2026-10-30: accessgudid.nlm.nih.gov/devices/10840199542632
• FDA Product Classification, GAD (Retractor), checked 2026-10-30: classification.cfm?id=GAD
• FDA Product Classification, GZT (Retractor, Self-Retaining, for Neurosurgery), checked 2026-10-30: classification.cfm?id=GZT