Cleared Traditional

COMET COSMIC 203/218 (K861527) - FDA 510(k) Clearance

K861527 · Fuyo U.S.A. Co., Ltd. · General & Plastic Surgery device
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Jul 1986
Decision
98d
Days
-
Risk

K861527 is an FDA 510(k) clearance for the COMET COSMIC 203/218.

Submitted by Fuyo U.S.A. Co., Ltd. (Bellevue, US). The FDA issued a Cleared decision on July 31, 1986 after a review of 98 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 Fuyo U.S.A. Co., Ltd. devices

Submission Details

510(k) Number K861527 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 24, 1986
Decision Date July 31, 1986
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -