Cleared Traditional

K950561 - KSEA DISPOSABLE TUBING SET FOR THE ARTH...

K950561 is the FDA 510(k) clearance for KSEA DISPOSABLE TUBING SET FOR THE ARTH... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K950561 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
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May 1995
Decision
93d
Days
Class 2
Risk

K950561 is an FDA 510(k) clearance for the KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 93 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-America, Inc. devices

Submission Details

510(k) Number K950561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1995
Decision Date May 12, 1995
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 K950561.
ARTHROSCOPIC TELESCOPES
K943052 · Karl Storz Endoscopy · May 1995
ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
K940179 · Richard Wolf Medical Instruments Corp. · May 1995
DANEK RIGID ARTHROSCOPE
K950501 · Sofamor Danek USA,Inc. · May 1995
INCLUSIVE ENDOSCOPE
K943356 · Danek Medical, Inc. · May 1995
BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS
K946151 · Depuy, Inc. · May 1995
MICRO-ENDO(TM) INSTRUMENTS
K950130 · Sofamor Danek USA,Inc. · May 1995