Cleared Traditional

K950373 - ULTRACELL ORTHOPEDIC SPONGES

K950373 is an FDA 510(k) clearance for ULTRACELL ORTHOPEDIC SPONGES, manufactured by Ultracell Medical Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K950373 · Ultracell Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
76d
Days
Class 1
Risk

K950373 is an FDA 510(k) clearance for the ULTRACELL ORTHOPEDIC SPONGES. 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 17, 1995 after a review of 76 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

FDA 510(k) Submission Details - K950373

510(k) Number K950373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date April 17, 1995
Days to Decision 76 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

GDY Device Classification - Class 1, General Controls

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.

Regulatory Peers - GDY Gauze/sponge, Internal, X-ray Detectable

All 57
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K950373.
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599 · Stryker Corp. · Feb 1996
ULTRACELL ORTHOPEDIC SPONGES
K950370 · Ultracell Medical Technologies, Inc. · Apr 1995
ULTRACELL ORTHOPEDIC SPONGES
K950372 · Ultracell Medical Technologies, Inc. · Apr 1995
ULTRACELL RETRACTOR COVERS
K950659 · Ultracell Medical Technologies, Inc. · Apr 1995
KITTNER DISSECTOR
K945333 · Lorrex Health Products · Dec 1994
CHERRY DISSECTOR
K945335 · Lorrex Health Products · Dec 1994