Cleared Traditional

K792100 - GRASPING FORCEP (W/FOUR PRONGS)
(FDA 510(k) Clearance)

Nov 1979
Decision
25d
Days
Class 1
Risk

K792100 is an FDA 510(k) clearance for the GRASPING FORCEP (W/FOUR PRONGS). This device is classified as a Forceps, General & Plastic Surgery (Class I - General Controls, product code GEN).

Submitted by Eder Instrument Co, Inc. (Walker, US). The FDA issued a Cleared decision on November 13, 1979, 25 days after receiving the submission on October 19, 1979.

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

Submission Details

510(k) Number K792100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1979
Decision Date November 13, 1979
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GEN — Forceps, General & Plastic Surgery
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800