Cleared Traditional

K153358 - Standard Clamp

K153358 is an FDA 510(k) clearance for Standard Clamp, manufactured by Standard Bariatrics. The device is a Class 1 General & Plastic Surgery device with product code GDJ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K153358 · Standard Bariatrics · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
164d
Days
Class 1
Risk

K153358 is an FDA 510(k) clearance for the Standard Clamp. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Standard Bariatrics (Cincinnati, US). The FDA issued a Cleared decision on May 2, 2016 after a review of 164 days - an extended review cycle.

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. Standard predicate reliance. 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 Standard Bariatrics devices

FDA 510(k) Submission Details - K153358

510(k) Number K153358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date May 02, 2016
Days to Decision 164 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 115d · This submission: 164d
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 16
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K153358.
THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE
K930315 · Thomasville Medical Assoc. · Feb 1994
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