Cleared Traditional

SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (K942526) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K942526 · Life Medical Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
53d
Days
Class 1
Risk

K942526 is an FDA 510(k) clearance for the SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM. Classified as System, Skin Closure (product code MKY), Class I - General Controls.

Submitted by Life Medical Sciences, Inc. (Princeton, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4320 - 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 Life Medical Sciences, Inc. devices

Submission Details

510(k) Number K942526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1994
Decision Date July 19, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MKY System, Skin Closure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4320
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.