Cleared Traditional

K973312 - TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING

K973312 · Innovative Technologies , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
49d
Days
-
Risk

K973312 is an FDA 510(k) clearance for the TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Innovative Technologies , Ltd. (Winsford, Cheshire, GB). The FDA issued a Cleared decision on October 22, 1997 after a review of 49 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 Innovative Technologies , Ltd. devices

FDA 510(k) Submission Details - K973312

510(k) Number K973312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1997
Decision Date October 22, 1997
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 K973312.
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