Cleared Traditional

K930697 - MEDLINE STERILE GAUZE SPONGES

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

K930697 · Medline Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K930697

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.

NAD Device Classification - Class 1, General Controls

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 50
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K930697.
DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
K960815 · Dumex Medical Surgical Products, Ltd. · Apr 1996
ALLDRESS MULTI LAYERED WOUND DRESSING
K955863 · Molnlycke/Scott Health Care · Mar 1996
OTOSILK
K952203 · Boston Medical Products, Inc. · Jul 1995
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K912022 · Fraass Survival Systems, Inc. · Aug 1991
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · Johnson & Johnson Medical, Inc. · Jan 1991
TENSOPLUS LITE
K901378 · Smith & Nephew United, Inc. · Jun 1990