Cleared Traditional

K934971 - STERILE LAPAROTOMY SPONGES

K934971 is an FDA 510(k) clearance for STERILE LAPAROTOMY SPONGES, manufactured by Medsurg Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDY cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K934971 · Medsurg Industries, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
112d
Days
Class 1
Risk

K934971 is an FDA 510(k) clearance for the STERILE LAPAROTOMY SPONGES. Classified as Gauze/sponge, Internal, X-ray Detectable (product code GDY), Class I - General Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medsurg Industries, Inc. devices

FDA 510(k) Submission Details - K934971

510(k) Number K934971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1993
Decision Date February 07, 1994
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
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 K934971.
ISOLYSER (4X18) X-RAY DETECTABLE
K940757 · Thantex Specialties, Inc. · May 1994
ISOLYSER (18X18 X-RAY DETECTABLE)
K940762 · Thantex Specialties, Inc. · May 1994
ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)
K940763 · Thantex Specialties, Inc. · May 1994
NEUROLOGICAL SPONGES
K935883 · Mcneil Healthcare, Inc. · Feb 1994
SURGICAL SPONGE X-RAY DETECTABLE
K935993 · Mcneil Healthcare, Inc. · Feb 1994
SPECIALTY SPONGES
K935881 · Mcneil Healthcare, Inc. · Jan 1994