Cleared Traditional

K930416 - SURGICAL SUTURE PACKAGE INSERTS

K930416 is an FDA 510(k) clearance for SURGICAL SUTURE PACKAGE INSERTS, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 457-day FDA review.

K930416 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
457d
Days
Class 2
Risk

K930416 is an FDA 510(k) clearance for the SURGICAL SUTURE PACKAGE INSERTS. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 457 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 878.4830 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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

FDA 510(k) Submission Details - K930416

510(k) Number K930416 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 26, 1993
Decision Date April 28, 1994
Days to Decision 457 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
342d slower than avg
Panel avg: 115d · This submission: 457d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAL Device Classification - Class 2, Special Controls

Product Code GAL Suture, Absorbable, Natural
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAL Suture, Absorbable, Natural

All 18
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K930416.
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
K991223 · Aesculap, Inc. · Apr 1999
PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
K961931 · R. K. Medical L. L. C. · Jul 1996
SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC
K930738 · Deknatel, Inc. · Jul 1994
REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES
K926586 · Look, Inc. · Dec 1993
PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR
K930589 · Davis & Geck, Inc. · Dec 1993
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
K904588 · United States Surgical, A Division of Tyco Healthc · Dec 1990