Cleared Traditional

K050158 - SINCLAIR SEBORRHEA EMULSION

K050158 · Sinclair Pharmaceuticals, Ltd. · General & Plastic Surgery device
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Oct 2006
Decision
624d
Days
-
Risk

K050158 is an FDA 510(k) clearance for the SINCLAIR SEBORRHEA EMULSION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sinclair Pharmaceuticals, Ltd. (Godalming, Surrey, GB). The FDA issued a Cleared decision on October 11, 2006 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Sinclair Pharmaceuticals, Ltd. devices

FDA 510(k) Submission Details - K050158

510(k) Number K050158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2005
Decision Date October 11, 2006
Days to Decision 624 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
509d slower than avg
Panel avg: 115d · This submission: 624d
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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