Cleared Traditional

K874428 - AUTO SUTURE PURSE STRING APPLIER*

K874428 is the FDA 510(k) clearance for AUTO SUTURE PURSE STRING APPLIER* by United States Surgical, A Division of Tyco Healthc. It is a Class 1 General & Plastic Surgery device (product code GDJ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K874428 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Dec 1987
Decision
35d
Days
Class 1
Risk

K874428 is an FDA 510(k) clearance for the AUTO SUTURE PURSE STRING APPLIER*. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on December 2, 1987 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K874428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date December 02, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K874428.
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
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