Cleared Traditional

KSEA POWERSHAVER SYSTEM S2 (K030009) - FDA 510(k) Clearance

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

K030009 · Karl Storz Endoscopy · Orthopedic device
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Apr 2003
Decision
90d
Days
Class 2
Risk

K030009 is an FDA 510(k) clearance for the KSEA POWERSHAVER SYSTEM S2. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on April 2, 2003 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 Karl Storz Endoscopy devices

Submission Details

510(k) Number K030009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2003
Decision Date April 02, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
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.

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 161
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K030009.
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
K051326 · Smith & Nephew, Inc. · Jun 2005
SMITH & NEPHEW VIDEOARTHROSCOPE
K043395 · Smith & Nephew, Inc. · Jan 2005
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · Smith & Nephew, Inc. · Jun 2003
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
K024291 · Arthrex, Inc. · Mar 2003
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
K030096 · Arthrex, Inc. · Mar 2003
DYONICS POWER CONTROL UNIT
K030196 · Smith & Nephew, Inc. · Feb 2003