Cleared Traditional

THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE

K930315 · Thomasville Medical Assoc. · General & Plastic Surgery
Feb 1994
Decision
378d
Days
Class 1
Risk

About This 510(k) Submission

K930315 is an FDA 510(k) clearance for the THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE, a Clamp, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDJ), submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 4, 1994, 378 days after receiving the submission on January 22, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K930315 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1993
Decision Date February 04, 1994
Days to Decision 378 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GDJ — Clamp, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

Similar Devices — GDJ Clamp, Surgical, General & Plastic Surgery

All 31
Standard Clamp
K153358 · Standard Bariatrics · May 2016
MAR-MED LIVER STRAP
K924223 · Mar-Med Co. · Mar 1993
GENERAL SURGERY CLAMP AND NEEDLE HOLDER
K922659 · Miltex Instrument Co. · Jul 1992
GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST
K914913 · Ideal Medical, Inc. · Dec 1991
GS-7100 CHOLANGIOGRAM CLAMP, 5MM
K900956 · Solos Endoscopy, Inc. · Apr 1990
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
K901107 · United States Surgical, A Division of Tyco Healthc · Apr 1990