Cleared Traditional

INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS (K983303) - FDA 510(k) Clearance

K983303 · Innovative Technologies , Ltd. · General & Plastic Surgery device

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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.

View all Innovative Technologies , Ltd. devices

Submission Details

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

Regulatory Context

Review time vs. panel average

36d faster than avg

Panel avg: 115d · This submission: 79d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K983303.

CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0

K981713 · Smith & Nephew, Inc. · Jul 1998

ULTEC THIN HYDROCOLLOID DRESSING

K952071 · Sherwood Medical Co. · Jun 1995

PROCEL BURN COVER

K915695 · W.L. Gore & Associates, Inc. · May 1992

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K983303

Innovative Technologies , Ltd.

Winsford, Cheshire · GB

CHRISTOPHER OAKES

Regulatory profile

14 submissions 11 cleared

79% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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