3M Frascia Stapling System

Q: What is the product code of K823888?

The FDA product code is GEF – Applier, Staple, Surgical,, a Class I (low risk) device regulated under 21 CFR 878.4800.

FDA 510(k) K823888 · 3M Company

Substantially Equivalent

510(k) numberK823888

Submission

Device name: 3M Frascia Stapling System
Applicant: 3M Company
White City, OR, US
Received: December 27, 1982
Decision date: January 9, 1983
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: GEF – Applier, Staple, Surgical,
Device class: Class I (low risk)
Regulation: 21 CFR 878.4800
Specialty: General, Plastic Surgery

Other 510(k)s with product code GEF

510(k)	Device	Applicant	Decision
K933508	Reflex SDD Surgical StaplerGEF · Traditional	Richard-Allan Medical	11/23/1993SE
K915670	Microaire Model 2600GEF · Traditional	Microaire	03/18/1992SE
K854568	V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional	American V. Mueller	12/02/1985SE

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Questions and answers

When was 3M Frascia Stapling System cleared by the FDA?

3M Frascia Stapling System (K823888) received a 510(k) decision of Substantially Equivalent on January 9, 1983, 13 days after the submission was received.

What is the product code of K823888?

The FDA product code is GEF – Applier, Staple, Surgical,, a Class I (low risk) device regulated under 21 CFR 878.4800.