Cleared Traditional

K863604 - DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE (FDA 510(k) Clearance)

K863604 · American Edwards Laboratories · General & Plastic Surgery device
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Oct 1986
Decision
17d
Days
-
Risk

K863604 is an FDA 510(k) clearance for the DISPOSABLE BLADES FOR ARTHROSCOPIC SURGICAL DEVICE.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 17 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 Edwards Laboratories devices

Submission Details

510(k) Number K863604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date October 03, 1986
Days to Decision 17 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
97d faster than avg
Panel avg: 114d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -