Microaire Model 2600

FDA 510(k) K915670 · Microaire

Substantially Equivalent

510(k) numberK915670

Submission

Device name
Microaire Model 2600
Applicant
Microaire
Valencia, CA, US
Received
December 19, 1991
Decision date
March 18, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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)DeviceApplicantDecision
K933508Reflex SDD Surgical StaplerGEF · Traditional Richard-Allan Medical11/23/1993SE
K854568V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional American V. Mueller12/02/1985SE
K8238883M Frascia Stapling SystemGEF · Traditional 3M Company01/09/1983SE

More from 3M Company

510(k)DeviceDecision
K912206Micro-Aire Arthros Surg Blades-Various Co Prod No.HRX · Traditional 08/16/1991SE
K912205Micro-Aire Arthros Surg Blades-Various Dys Prod NoHRX · Traditional 08/16/1991SE

Questions and answers

When was Microaire Model 2600 cleared by the FDA?

Microaire Model 2600 (K915670) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 90 days after the submission was received.

What is the product code of K915670?

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