Cleared Traditional

OPERAND SUTURE REMOVAL TRAY (K822577) - FDA 510(k) Clearance

K822577 · Medcare Products · General & Plastic Surgery device
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Oct 1982
Decision
58d
Days
-
Risk

K822577 is an FDA 510(k) clearance for the OPERAND SUTURE REMOVAL TRAY.

Submitted by Medcare Products (Walker, US). The FDA issued a Cleared decision on October 22, 1982 after a review of 58 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.

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Submission Details

510(k) Number K822577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1982
Decision Date October 22, 1982
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -