Cleared Traditional

K874879 - AUTO SUTURE SURGIPORT DISPOS SURG TROCA...

K874879 is an FDA 510(k) clearance for AUTO SUTURE SURGIPORT DISPOS SURG TROCA..., manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 1 General & Plastic Surgery device with product code GDH cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K874879 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
38d
Days
Class 1
Risk

K874879 is an FDA 510(k) clearance for the AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE. Classified as Gouge, Surgical, General & Plastic Surgery (product code GDH), Class I - General Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on December 17, 1987 after a review of 38 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

FDA 510(k) Submission Details - K874879

510(k) Number K874879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date December 17, 1987
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

GDH Device Classification - Class 1, General Controls

Product Code GDH Gouge, 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 - GDH Gouge, Surgical, General & Plastic Surgery

Devices cleared under the same product code (GDH) and FDA review panel - the closest regulatory comparables to K874879.
MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE
K903419 · United States Surgical, A Division of Tyco Healthc · Aug 1990
MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
K900487 · United States Surgical, A Division of Tyco Healthc · Feb 1990
GOUGES, ALEXANDER, BISHOP, LUCAS
K891901 · Zinnanti Surgical Instruments, Inc. · Apr 1989
PARKES HUMP GAUGE STRAIGHT 7 (18 CM)
K760850 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976