Cleared Traditional

ARTHOSCOPE (K960805) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960805 · United States Surgical, A Division of Tyco Healthc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
42d
Days
Class 2
Risk

K960805 is an FDA 510(k) clearance for the ARTHOSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on April 10, 1996 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K960805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1996
Decision Date April 10, 1996
Days to Decision 42 days
Submission Type Traditional
Review Panel Orthopedic (OR)
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: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 176
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K960805.
KARL STORZ MAGNIFYING ARTHROSOCPES
K961228 · KARL STORZ Endoscopy-America, Inc. · Oct 1996
INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY
K961713 · KARL STORZ Endoscopy-America, Inc. · May 1996
KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME
K961244 · KARL STORZ Endoscopy-America, Inc. · May 1996
PERCUTANEOUS ENDOSCOPIC DISCECTOMY
K960222 · Richard Wolf Medical Instruments Corp. · Mar 1996
AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS
K954652 · Aesculap, Inc. · Feb 1996
BOZOTTA REINSERTION FORCEPS
K955480 · KARL STORZ Endoscopy-America, Inc. · Feb 1996