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This page describes products and general use; it is not medical advice.
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Short answer: an absorbable staple is a skin-closure staple made of a material the body gradually degrades and absorbs, applied with a single-use hand-held stapler. One named product of this type in the FDA records is the Insorb subcuticular skin stapler. This guide is for clinic staff, supply buyers and students who need to tell absorbable staples apart from metal skin staples and read how FDA identifies them.
What are absorbable staples?
The Global Medical Device Nomenclature (“Skin stapler/staple, bioabsorbable”) describes the device as a hand-held manual surgical instrument, preloaded with bioabsorbable skin staples, designed to apply the staples to approximate the free skin edges of an incision or wound. The staples, which may be clip-like, are made of material that is gradually degraded and absorbed by the body, typically a biodegradable polymer. GMDN states that it is a single-use device.
Who uses it: the FDA definition of a surgical stapler for external use calls it a specialized prescription device used to deliver compatible staples to skin during surgery.
How is an absorbable skin stapler built?
Per the GMDN description, the instrument is preloaded: the staples ship inside the stapler rather than being loaded separately. The U.S. device records for the Insorb subcuticular skin stapler (references 2030 and 1008, labeler CooperSurgical, Inc.) list each as a single unit that is sterile and single-use. No staple dimensions, polymer composition or absorption time are given in the public FDA records, so this page does not state them; the manufacturer’s instructions for use are the place to find them.
Types and variants
Searches use several names for this product family. “Insorb staples”, “absorbable skin staples” and “absorbable staples” point to the same class of device. A metal “skin stapler” is a different class, as the table shows.
| Type | FDA product code and name | Class and regulation | Key difference |
|---|---|---|---|
| Absorbable staple (Insorb) | GDW, Staple, Implantable | Class 2, 21 CFR 878.4750 | Staple that stays in the body and is absorbed; cleared under GDW in the Insorb 510(k)s |
| Skin stapler (instrument) | QQS, Stapler, Skin | Class 1, 21 CFR 878.4740 | Surgical stapler for external use; delivers compatible staples to skin |
| Surgical stapler (internal use) | GAG, Stapler, Surgical | Class 2, 21 CFR 878.4740 | Delivers compatible staples to internal tissues during resection, transection and anastomoses |
Source: openFDA device classification records, checked 2026-10-30. For the wider stapler families see surgical stapler types.
What the FDA record shows for Insorb
The openFDA 510(k) database lists five premarket notifications for Insorb absorbable staples from applicant Incisive Surgical, Inc., all under product code GDW and all with a decision of “Substantially Equivalent”.
| 510(k) | Decision date | Device name as listed | Type |
|---|---|---|---|
| K024117 | 2003-04-22 | Insorb Absorbable Staples, Model SP-B20 | Traditional |
| K033602 | 2003-12-16 | Insorb Absorbable Staple, Model SP-B20 | Special |
| K061784 | 2006-07-26 | Insorb Absorbable Staple, Model 1020 | Special |
| K090159 | 2009-02-06 | Insorb Absorbable Staple, Models 1020, 1025 and other product families | Special |
| K120373 | 2012-03-16 | Insorb Absorbable Staple | Special |
Source: openFDA 510(k) API, checked 2026-10-30. A 510(k) decision is a clearance record; it says nothing about which model is on the market today. The two Insorb entries in the FDA UDI database (AccessGUDID) differ on distribution status, so confirm current availability with the supplier.
Why the regulation text says “not absorbable”
Product code GDW is Class 2 under 21 CFR 878.4750, which identifies an implantable staple as a staple-like device intended to connect internal tissues to aid healing and adds: “It is not absorbable.” Yet FDA’s database files Insorb absorbable staples under GDW. This page reports both facts as they appear in the primary records and draws no legal conclusion; the practical lesson for readers is that the regulation number on a record and the plain-language name of a product do not always line up, so read the 510(k) record itself.
Safe use and handling basics
- The device records list the Insorb stapler as sterile and single-use, so it is not designed to be reprocessed.
- FDA describes skin staplers as prescription devices, used during surgery by the clinician.
- Application technique, indications and contraindications belong to the manufacturer’s instructions for use, which this page does not replace.
Common mistakes
- Treating “skin stapler” and “absorbable staple” as one thing. Under FDA codes the stapler instrument (QQS, Class 1) and the implantable staple (GDW, Class 2) are different entries.
- Reading a 510(k) list as a current catalogue. The oldest Insorb clearance dates to 2003 and the latest to 2012.
- Assuming the regulation number alone defines the product. See the section above on 21 CFR 878.4750.
Related reading
Absorbable sutures are the other absorbable option for closing tissue; see what is a suture and absorbable vs non-absorbable sutures. For a non-staple skin closure product, see Clozex skin closure.
Frequently asked questions
Are absorbable staples removed?
GMDN describes the staples as made of material gradually degraded and absorbed by the body. Removal instructions, if any, are in the manufacturer’s instructions for use; this page gives no procedure steps.
Is an Insorb stapler reusable?
No. The FDA UDI records list the Insorb subcuticular skin stapler as single-use and sterile.
What FDA class are absorbable staples?
The Insorb staples were cleared under product code GDW, listed as Class 2 (21 CFR 878.4750). The skin stapler instrument code QQS is listed as Class 1.
Sources
- openFDA device 510(k) API, search for Insorb: https://api.fda.gov/device/510k.json?search=device_name:%22insorb%22, checked 2026-10-30.
- openFDA device classification API, product codes GDW, QQS and GAG: https://api.fda.gov/device/classification.json?search=product_code:GDW, checked 2026-10-30.
- openFDA / AccessGUDID UDI records, brand INSORB (includes the GMDN definition quoted above): https://api.fda.gov/device/udi.json?search=brand_name:insorb, checked 2026-10-30.
- 21 CFR 878.4750 Implantable staple: https://www.law.cornell.edu/cfr/text/21/878.4750, checked 2026-10-30.
