Cleared Traditional

K885096 - PHYNE-VU

K885096 · Medical Resources, Ltd. · General & Plastic Surgery device
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Jul 1989
Decision
228d
Days
-
Risk

K885096 is an FDA 510(k) clearance for the PHYNE-VU. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medical Resources, Ltd. (Lakeland, US). The FDA issued a Cleared decision on July 25, 1989 after a review of 228 days - an extended review 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: 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 Medical Resources, Ltd. devices

FDA 510(k) Submission Details - K885096

510(k) Number K885096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1988
Decision Date July 25, 1989
Days to Decision 228 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
113d slower than avg
Panel avg: 115d · This submission: 228d
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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