Cleared Traditional

K950370 - ULTRACELL ORTHOPEDIC SPONGES

K950370 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.

K950370 · 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

K950370 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 - K950370

510(k) Number K950370 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
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 13
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K950370.
STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
K955599 · Stryker Corp. · Feb 1996
STERILE LAPAROTOMY SPONGES
K934971 · Medsurg Industries, Inc. · Feb 1994
SUAN FLAT DISSECTOR SPONGES
K914082 · Icn Pharmaceuticals, Inc. · Nov 1991
ICAN K DISSECTOR SPONGES
K914083 · Icn Pharmaceuticals, Inc. · Oct 1991
ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
K903358 · Advance Medical Designs, Inc. · Nov 1990
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · Deroyal Industries, Inc. · Dec 1988