Cleared Traditional

K943323 - STRYKER SURGICAL INSTRUMENTS AND ACCESS...

K943323 is the FDA 510(k) clearance for STRYKER SURGICAL INSTRUMENTS AND ACCESS... by Stryker Corp.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K943323 · Stryker Corp. · Orthopedic device
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Nov 1994
Decision
140d
Days
Class 2
Risk

K943323 is an FDA 510(k) clearance for the STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Stryker Corp. (Portage, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 140 days - within the typical 510(k) review window.

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 Stryker Corp. devices

Submission Details

510(k) Number K943323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1994
Decision Date November 28, 1994
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K943323.
THE KARL STORZ ARTHROPUMP
K942298 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
TRANSTIBIAL ACL DISPOSABLES KIT
K943943 · Arthrex, Inc. · Dec 1994
KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS
K943154 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
MENISCAL SUTURE INSTRUMENTARIUM
K940287 · Richard Wolf Medical Instruments Corp. · Nov 1994
DANEKSCOPE OPTI-PROBE
K943676 · Danek Medical, Inc. · Nov 1994
SE5 ARTHROSCOPY SYTEM
K941333 · Stryker Endoscopy · Nov 1994