Cleared Traditional

K983303 - INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS

K983303 · Innovative Technologies , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
79d
Days
-
Risk

K983303 is an FDA 510(k) clearance for the INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESS.... 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 December 9, 1998 after a review of 79 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.

FDA 510(k) Submission Details - K983303

510(k) Number K983303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1998
Decision Date December 09, 1998
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 79
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K983303.
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
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K990438 · Dermaphylyx, Inc. · Mar 1999
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · Molnlycke Health Care, Inc. · Mar 1999
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
K983234 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 1998
MODIFICATION TO TIELLE HYDROPOLMER DRESSING
K983394 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 1998
MEPILEX
K983184 · Molnlycke Health Care, Inc. · Oct 1998
K983303 · INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS
Download PDF FDA Summary Innovative Technologi…