Cleared Traditional

K941036 - CURVED ROTATABLE DISPOSABLE ARTHROSCOPI...

K941036 is the FDA 510(k) clearance for CURVED ROTATABLE DISPOSABLE ARTHROSCOPI... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K941036 · Smith & Nephew, Inc. · Orthopedic device
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Sep 1994
Decision
205d
Days
Class 2
Risk

K941036 is an FDA 510(k) clearance for the CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on September 28, 1994 after a review of 205 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K941036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date September 28, 1994
Days to Decision 205 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 122d · This submission: 205d
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 K941036.
SE5 ARTHROSCOPY SYTEM
K941333 · Stryker Endoscopy · Nov 1994
LIMITED REUSE BLADES
K943985 · Linvatec Corp. · Nov 1994
ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS
K940290 · Acufex Microsurgical, Inc. · Sep 1994
MANUAL SURGICAL INSTRUMENTS
K942079 · Acufex Microsurgical, Inc. · Sep 1994
ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA
K942834 · Acufex Microsurgical, Inc. · Sep 1994
ACUFEX(R) ENDO-FEMORAL AIMER
K942846 · Acufex Microsurgical, Inc. · Sep 1994