Cleared Traditional

K930697 - MEDLINE STERILE GAUZE SPONGES

K930697 is the FDA 510(k) clearance for MEDLINE STERILE GAUZE SPONGES by Medline Industries, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAD) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K930697 · Medline Industries, Inc. · General & Plastic Surgery device
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Jun 1993
Decision
134d
Days
Class 1
Risk

K930697 is an FDA 510(k) clearance for the MEDLINE STERILE GAUZE SPONGES. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 24, 1993 after a review of 134 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K930697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date June 24, 1993
Days to Decision 134 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 115d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 23
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K930697.
WET CHAMBER
K020781 · Kinetic Concepts, Inc. · May 2002
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · Johnson & Johnson Medical, Inc. · Jan 1991
DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
K892527 · Convatec, A Division of E.R. Squibb & Sons · May 1989
DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING
K891696 · Convatec, A Division of E.R. Squibb & Sons · May 1989
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · 3M Company · Apr 1989
POLYMER ADHESIVE BANDAGE
K883391 · Marion Laboratories, Inc. · Mar 1989