Cleared Traditional

K922391 - ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS

K922391 is an FDA 510(k) clearance for ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS, manufactured by Instratek, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K922391 · Instratek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
90d
Days
Class 2
Risk

K922391 is an FDA 510(k) clearance for the ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Instratek, Inc. (Houston, US). The FDA issued a Cleared decision on August 18, 1992 after a review of 90 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 Instratek, Inc. devices

FDA 510(k) Submission Details - K922391

510(k) Number K922391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date August 18, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

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 456
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K922391.
ARTHREX ARTHROSCOPY ICE BLADE
K921823 · Arthrex, Inc. · Oct 1992
ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT
K922557 · Acufex Microsurgical, Inc. · Sep 1992
CLEARTRAC CANNULA
K920454 · Acufex Microsurgical, Inc. · Sep 1992
DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET
K922318 · Douglas Medical Products Corp. · Aug 1992
INTEGRATED ENDOSCOPY SYSTEM 1000
K920800 · Biomet, Inc. · Jun 1992
SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET
K914963 · Smith & Nephew Dyonics, Inc. · Jun 1992