Cleared Traditional

K973855 - IT HYDROCOLLOID WITH ZINC

K973855 · Innovative Technologies , Ltd. · General & Plastic Surgery device
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Dec 1997
Decision
53d
Days
-
Risk

K973855 is an FDA 510(k) clearance for the IT HYDROCOLLOID WITH ZINC. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Innovative Technologies , Ltd. (Winsford, Cheshire, GB). The FDA issued a Cleared decision on December 1, 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 Innovative Technologies , Ltd. devices

FDA 510(k) Submission Details - K973855

510(k) Number K973855 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 09, 1997
Decision Date December 01, 1997
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
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.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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