Cleared Traditional

K935882 - TONSIL SPONGES

K935882 is an FDA 510(k) clearance for TONSIL SPONGES, manufactured by Mcneil Healthcare, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K935882 · Mcneil Healthcare, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
53d
Days
Class 1
Risk

K935882 is an FDA 510(k) clearance for the TONSIL SPONGES. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Mcneil Healthcare, Inc. (Waterford, US). The FDA issued a Cleared decision on January 31, 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 878.4450 - 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 Mcneil Healthcare, Inc. devices

FDA 510(k) Submission Details - K935882

510(k) Number K935882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1993
Decision Date January 31, 1994
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
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 38
Devices cleared under the same product code (GDY) and FDA review panel - the closest regulatory comparables to K935882.
ISOLYSER (18X18 X-RAY DETECTABLE)
K940762 · Thantex Specialties, Inc. · May 1994
ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
K940763 · Thantex Specialties, Inc. · May 1994
STERILE LAPAROTOMY SPONGES
K934971 · Medsurg Industries, Inc. · Feb 1994
SPECIALTY SPONGES
K920355 · Ultracell Medical Technologies, Inc. · Aug 1992
SURGICAL SPONGES
K920356 · Ultracell Medical Technologies, Inc. · Aug 1992
SUAN FLAT DISSECTOR SPONGES
K914082 · Icn Pharmaceuticals, Inc. · Nov 1991