Written and maintained by CASRAI Editorial Board
Published · Last updated
This page describes products and general use; it is not medical advice.
On this page
“Medical staple gun” is the everyday name for a surgical skin stapler: a hand-held applier that places metal staples in the skin or scalp to hold a wound edge together. The staples are later taken out with a staple remover. In US regulation these are separate device records, and the remover side is the part most pages leave out. This guide is for clinic staff, supply buyers and students who need to know what the product class is and how FDA classifies it.
What is a medical staple gun?
FDA describes surgical staplers and staples for external use as devices “used outside the body to close large wounds or surgical cuts on a patient’s skin or scalp.” That is the device people search for as a medical staple gun, skin stapler, surgical skin stapler or stapler for stitches. Despite the name it is unrelated to an office or construction staple gun: it is a sterile medical device used by a clinician.
Who uses it: clinicians who close skin or scalp wounds; the supply side is handled by clinic, hospital and procurement staff.
How the system is built: stapler, staples and remover
Under FDA’s records, the “staple gun” is really three related items, each with its own product code:
- The staples. 21 CFR 878.4760 defines a removable skin staple as “a staple-like device intended to connect external tissues temporarily to aid healing” that “is not absorbable” (FDA product code GDT, “Staple, Removable (Skin)”).
- The applier. The hand-held tool that places staples falls under 21 CFR 878.4800, the manual surgical instrument for general use, which covers non-powered, hand-held or hand-manipulated devices that may be reusable or disposable (product code GEF, “Applier, Staple, Surgical”).
- The remover. Staple removal kits carry product code PYE, “Staple Removal Kit”, also under 21 CFR 878.4760.
Types and variants: how skin staplers differ from other staplers
Searches for “surgery stapler” mix several different device classes. The table separates them using FDA and CFR records.
| Type | Typical use | Key difference (FDA class, code) |
|---|---|---|
| Removable skin staple (surgical skin stapler) | External closure of skin or scalp wounds | Non-absorbable, temporary; Class I, regulation 878.4760, code GDT |
| Staple applier | Hand-held tool that places staples | General-use manual instrument; Class I, regulation 878.4800, code GEF |
| Staple removal kit | Removing skin staples | Convenience kit; Class I, regulation 878.4760, code PYE |
| Absorbable staple | Closure that is not removed (see absorbable staples) | Class 2, regulation 888.3030, code MNU |
| Internal-use surgical stapler | Resection, transection and anastomoses inside the body (see surgical stapler types) | Reclassified from Class I to Class II by FDA’s October 2021 final order; implantable staple code GDW, regulation 878.4750 |
The 2021 reclassification applies to staplers for internal use. It should not be read as covering external skin staplers, whose staple regulation (878.4760) is Class I.
Regulatory status: what Class I and 510(k)-exempt mean here
21 CFR 878.4760 classifies the removable skin staple as Class I (general controls) and exempts it from premarket notification (510(k)), subject to the limitations in 21 CFR 878.9. The regulation text was published in 1988 and amended in 2000. The staple removal kit (PYE) is described in FDA’s classification database as a convenience kit handled under enforcement discretion under a May 20, 1997 guidance, so no 510(k) is needed if the kit meets the guidance criteria.
These records establish how the devices are classified. They do not describe sizes, wire materials or staple counts: those vary by manufacturer and are given in each product’s instructions for use, which is also the only place to find a particular model’s directions.
Are surgical staples better than stitches?
FDA lists these advantages for surgical staples: quick placement, minimal tissue reaction, low risk of infection and strong wound closure. FDA does not frame this as staples being better than sutures overall, and the choice of closure for a given wound is a clinical decision made by the treating clinician. For the suture side of the comparison, see what a suture is; for glue-type closure, see skin adhesives.
What is the tool that removes staples called?
It is called a staple remover (also searched as a skin staple remover or sterile staple remover). In FDA’s records, removers supplied as a package are listed as “Staple Removal Kit” under product code PYE. This page does not cover how staples are removed from a patient; that is a clinical procedure performed according to the clinician’s orders and the device’s instructions for use.
What are skin staplers, and what happens in one?
A skin stapler is the hand-held applier described above, loaded with removable staples. At a product level, it is a single-purpose instrument for external closure. Step-by-step use belongs to clinical training and the manufacturer’s instructions for use, not to a general reference, so it is not described here.
Safe use and handling basics
- Use the device only as its manufacturer’s instructions for use direct, and by trained clinicians.
- FDA asks that problems with surgical staplers and staples be reported through its MedWatch program.
Common mistakes
- Treating all “surgical staplers” as one class. External skin staples (Class I, 878.4760) and internal-use staplers (Class II since 2021) are separate.
- Assuming staples are absorbable. The 878.4760 definition is explicitly non-absorbable; absorbable staples are a different code (MNU).
- Forgetting the remover. Because skin staples are temporary and not absorbable, removal is part of the product system, and removal kits (PYE) are a separate item.
Frequently asked questions
Is a medical staple gun the same as a surgical skin stapler?
Yes. Both names describe a hand-held applier that places removable skin staples; “staple gun” is the informal term.
Are skin staples absorbable?
The staples in 21 CFR 878.4760 are not absorbable. Absorbable skin staplers are a separate class (see absorbable staples).
Is a skin stapler regulated by FDA?
Yes. The removable skin staple is Class I and 510(k)-exempt under 21 CFR 878.4760.
Sources
- FDA, Surgical Staplers and Staples (checked 2026-11-07).
- 21 CFR 878.4760, Removable skin staple, Cornell LII (checked 2026-11-07).
- 21 CFR 878.4800, Manual surgical instrument for general use, Cornell LII (checked 2026-11-07).
- FDA, openFDA device classification database, product codes GDT, PYE, GEF, MNU, GDW (checked 2026-11-07).
Related reading: surgical instruments names and pictures, wound closure kits.
