Cleared Traditional

K911180 - CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS
(FDA 510(k) Clearance)

Mar 1991
Decision
11d
Days
Class 1
Risk

K911180 is an FDA 510(k) clearance for the CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS. This device is classified as a Forceps (Class I - General Controls, product code HTD).

Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on March 29, 1991, 11 days after receiving the submission on March 18, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K911180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date March 29, 1991
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code HTD — Forceps
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800