Cleared Traditional

ULTRACELL RETRACTOR COVERS (K950659) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K950659 · Ultracell Medical Technologies, Inc. · General & Plastic Surgery device
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Apr 1995
Decision
59d
Days
Class 1
Risk

K950659 is an FDA 510(k) clearance for the ULTRACELL RETRACTOR COVERS. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Ultracell Medical Technologies, Inc. (Old Mystic, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4450 - 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 Ultracell Medical Technologies, Inc. devices

Submission Details

510(k) Number K950659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date April 13, 1995
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDY Gauze/sponge, Internal, X-ray Detectable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4450
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.