Cleared Traditional

K093471 - KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP

K093471 is an FDA 510(k) clearance for KARL STORZ ARTHROPUMP POWER IRRIGATION/..., manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K093471 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
346d
Days
Class 2
Risk

K093471 is an FDA 510(k) clearance for the KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on October 18, 2010 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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-America, Inc. devices

FDA 510(k) Submission Details - K093471

510(k) Number K093471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2009
Decision Date October 18, 2010
Days to Decision 346 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
224d slower than avg
Panel avg: 122d · This submission: 346d
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 523
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K093471.
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K113362 · Spine View, Inc. · Feb 2012
MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS
K113028 · Medisiss · Dec 2011
ENSPIRE DEBRIDER SYSTEM
K110992 · Spine View, Inc. · Oct 2011
KYPHON XPANDER II INFLATABLE BONE TAMP
K101864 · Medtronic · Oct 2010
AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM
K092723 · Skeletal Dynamics, LLC · Oct 2010
STRYKER ARTHROSCOPE
K093677 · Stryker Endoscopy · Mar 2010