Cleared Traditional

K971861 - ULTRASONIC HAND INSTRUMENTS

K971861 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
42d
Days
-
Risk

K971861 is an FDA 510(k) clearance for the ULTRASONIC HAND INSTRUMENTS. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on July 1, 1997 after a review of 42 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K971861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date July 01, 1997
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 88
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K971861.
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K970471 · Mentor Corp. · Jul 1997
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K971302 · Ethicon Endo-Surgery, Inc. · Jul 1997
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
K964601 · Valleylab, Inc. · Jan 1997
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
K962584 · Ethicon Endo-Surgery, Inc. · Nov 1996
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
K960040 · Sharplan Lasers, Inc. · Apr 1996