Cleared Traditional

K930416 - SURGICAL SUTURE PACKAGE INSERTS (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930416 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
343d slower than avg
Panel avg: 114d · This submission: 457d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.