Cleared Traditional

K871675 - FERRIS TRANSPARENT WOUND DRESSING W/HYD...

K871675 · Ferris Mfg. Corp. · General & Plastic Surgery device
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Aug 1987
Decision
100d
Days
-
Risk

K871675 is an FDA 510(k) clearance for the FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on August 6, 1987 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ferris Mfg. Corp. devices

Submission Details

510(k) Number K871675 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 28, 1987
Decision Date August 06, 1987
Days to Decision 100 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 223
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K871675.
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COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913 · Beiersdorf, Inc. · Jul 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · American Pharmaseal Div. Ahsc · Jun 1987