Cleared Traditional

K964534 - OTOSILK OTOLOGICAL GRAFT DRESSING

K964534 is an FDA 510(k) clearance for OTOSILK OTOLOGICAL GRAFT DRESSING, manufactured by Boston Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K964534 · Boston Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
148d
Days
Class 1
Risk

K964534 is an FDA 510(k) clearance for the OTOSILK OTOLOGICAL GRAFT DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on April 9, 1997 after a review of 148 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 Boston Medical Products, Inc. devices

FDA 510(k) Submission Details - K964534

510(k) Number K964534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1996
Decision Date April 09, 1997
Days to Decision 148 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
33d slower than avg
Panel avg: 115d · This submission: 148d
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 44
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K964534.
WET CHAMBER
K020781 · Kinetic Concepts, Inc. · May 2002
OTOSILK
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MEDLINE STERILE GAUZE SPONGES
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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