Cleared Traditional

K960473 - AESCULAP POWER SYSTEM HANDPIECE

K960473 is an FDA 510(k) clearance for AESCULAP POWER SYSTEM HANDPIECE, manufactured by Aesculap, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GET cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K960473 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
35d
Days
Class 1
Risk

K960473 is an FDA 510(k) clearance for the AESCULAP POWER SYSTEM HANDPIECE. Classified as Motor, Surgical Instrument, Pneumatic Powered (product code GET), Class I - General Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 7, 1996 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K960473

510(k) Number K960473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1996
Decision Date March 07, 1996
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

GET Device Classification - Class 1, General Controls

Product Code GET Motor, Surgical Instrument, Pneumatic Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GET Motor, Surgical Instrument, Pneumatic Powered

All 10
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