Cleared Traditional

K873809 - EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001

K873809 is an FDA 510(k) clearance for EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001, manufactured by Zimmer Aspen Labs. The device is a Class 2 General & Plastic Surgery device with product code BWA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K873809 · Zimmer Aspen Labs · General & Plastic Surgery device
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Nov 1987
Decision
63d
Days
Class 2
Risk

K873809 is an FDA 510(k) clearance for the EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001. Classified as Unit, Electrosurgical And Coagulation, With Accessories (product code BWA), Class II - Special Controls.

Submitted by Zimmer Aspen Labs (Englewood, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. 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 Zimmer Aspen Labs devices

FDA 510(k) Submission Details - K873809

510(k) Number K873809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1987
Decision Date November 20, 1987
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWA Device Classification - Class 2, Special Controls

Product Code BWA Unit, Electrosurgical And Coagulation, With Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.