Cleared Traditional

K930315 - THORACIC CLAMPS: SAROT

K930315 is an FDA 510(k) clearance for THORACIC CLAMPS: SAROT, manufactured by Thomasville Medical Assoc.. The device is a Class 1 General & Plastic Surgery device with product code GDJ cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K930315 · Thomasville Medical Assoc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
378d
Days
Class 1
Risk

K930315 is an FDA 510(k) clearance for the THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Thomasville Medical Assoc. devices

FDA 510(k) Submission Details - K930315

510(k) Number K930315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 115d · This submission: 378d
Pathway characteristics
Predicate-based equivalence.

GDJ Device Classification - Class 1, General Controls

Product Code GDJ Clamp, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDJ Clamp, Surgical, General & Plastic Surgery

All 15
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K930315.
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
K901107 · United States Surgical, A Division of Tyco Healthc · Apr 1990
SURGICAL DUCT CLAMP (VINE)
K882169 · Henley Intl. · Jun 1988
AUTO SUTURE PURSE STRING APPLIER*
K874428 · United States Surgical, A Division of Tyco Healthc · Dec 1987
TOURIQUET KIT WITH SNARE
K855144 · Dlp, Inc. · Feb 1986
BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420
K852724 · The Huxley Instrument Corp. · Jul 1985
17-900 TO 17-980 VARIOUS TOWEL CLAMPS
K851774 · Artiberia · Jun 1985