Cleared Traditional

K973260 - HYDRASORB STERILE DRESSING

K973260 · Avitar, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
53d
Days
-
Risk

K973260 is an FDA 510(k) clearance for the HYDRASORB STERILE DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Avitar, Inc. (Canton, US). The FDA issued a Cleared decision on October 21, 1997 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Avitar, Inc. devices

FDA 510(k) Submission Details - K973260

510(k) Number K973260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1997
Decision Date October 21, 1997
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 35
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K973260.
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
K973036 · 3M Healthcare · Nov 1997
SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED
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TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
K973312 · Innovative Technologies , Ltd. · Oct 1997
LYOCELL WOUND DRESSING/SURGICAL SPONGE
K972458 · Courtaulds Fibers, Inc. · Sep 1997
OPPORTUNITY I.V. START KIT
K971093 · Opportunity, Inc. · Sep 1997
ALGOPLAQUE HYDROCOLLOID DRESSING
K970518 · Laboratoires Urgo S.A. · Mar 1997