Cleared Traditional

K871770 - AMERICAN PHARMASEAL WOUND DRESSING

K871770 · American Pharmaseal Div. Ahsc · General & Plastic Surgery device
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Jun 1987
Decision
51d
Days
-
Risk

K871770 is an FDA 510(k) clearance for the AMERICAN PHARMASEAL WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on June 26, 1987 after a review of 51 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K871770

510(k) Number K871770 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 06, 1987
Decision Date June 26, 1987
Days to Decision 51 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
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 227
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