Cleared Traditional

K904578 - MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K904578 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Oct 1990
Decision
28d
Days
Class 1
Risk

K904578 is an FDA 510(k) clearance for the MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP. Classified as Motor, Surgical Instrument, Pneumatic Powered (product code GET), Class I - General Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on October 30, 1990 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 K904578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date October 30, 1990
Days to Decision 28 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
86d faster than avg
Panel avg: 114d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GET Motor, Surgical Instrument, Pneumatic Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.