Cleared Traditional

DISPOSABLE ARTHROSCOPIC ACCESSORY (K933949) - FDA 510(k) Clearance

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

K933949 · United States Surgical, A Division of Tyco Healthc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
218d
Days
Class 2
Risk

K933949 is an FDA 510(k) clearance for the DISPOSABLE ARTHROSCOPIC ACCESSORY. 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 March 18, 1994 after a review of 218 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K933949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1993
Decision Date March 18, 1994
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 K933949.
ARTHTOTEK PRECISION HAND INSTRUMENTATION
K933070 · Biomet, Inc. · Mar 1994
ARTHROTEK CANNULA SYSTEM
K934401 · Biomet, Inc. · Mar 1994
GORE SMOOTHER CRUCIAL TOOL
K936206 · W.L. Gore & Associates, Inc. · Mar 1994
ARTHREX TIBIAL TUNNEL CANNULA
K930152 · Arthrex, Inc. · Mar 1994
ARTHREX INSTRUMENTS ( HIP )
K926212 · Arthrex, Inc. · Jan 1994
ARTHREX INSTRUMENTS (WRIST)
K926303 · Arthrex, Inc. · Jan 1994