Cleared Traditional

K010345 - KSEA MANHES TAKE-APART BIPOLAR COAGULAT...

K010345 is the FDA 510(k) clearance for KSEA MANHES TAKE-APART BIPOLAR COAGULAT... 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 179-day FDA review.

K010345 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
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Aug 2001
Decision
179d
Days
Class 2
Risk

K010345 is an FDA 510(k) clearance for the KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS. 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 August 3, 2001 after a review of 179 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K010345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2001
Decision Date August 03, 2001
Days to Decision 179 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
57d slower than avg
Panel avg: 122d · This submission: 179d
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 K010345.
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
K012635 · Alliance Medical Corp. · Nov 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536 · Sterilmed, Inc. · Nov 2001
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · Vanguard Medical Concepts, Inc. · Oct 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
K011083 · Arthrocare Corp. · Jun 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · KARL STORZ Endoscopy-America, Inc. · Jun 2001
PERC-D SPINEWAND
K010811 · Arthrocare Corp. · May 2001