Cleared Traditional

K901617 - ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM...

K901617 is the FDA 510(k) clearance for ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K901617 · Smith & Nephew, Inc. · Orthopedic device
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May 1990
Decision
53d
Days
Class 2
Risk

K901617 is an FDA 510(k) clearance for the ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR). Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on May 29, 1990 after a review of 53 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K901617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1990
Decision Date May 29, 1990
Days to Decision 53 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 122d · This submission: 53d
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 K901617.
SHEPPERD CUTTING FORCEPS
K900616 · Downs Surgical , Ltd. · Oct 1990
ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
K901735 · Micro-Aire Surgical Instruments, Inc. · Jun 1990
ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
K902168 · Micro-Aire Surgical Instruments, Inc. · Jun 1990
MEDICAM ARTHROSCOPE SYSTEMS
K900812 · Kirschner Medical Corp. · May 1990
SILICONE PLUG
K896678 · Orthopedic Systems, Inc. · Jan 1990
ARTHROSCOPIC TUBING SHEATH
K896584 · Origin Medsystems, Inc. · Dec 1989