Cleared Traditional

K023187 - KSEA SPINOSCOPE

K023187 is the FDA 510(k) clearance for KSEA SPINOSCOPE by Karl Storz Endoscopy. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K023187 · Karl Storz Endoscopy · Orthopedic device
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Dec 2002
Decision
69d
Days
Class 2
Risk

K023187 is an FDA 510(k) clearance for the KSEA SPINOSCOPE. 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 December 2, 2002 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Karl Storz Endoscopy devices

Submission Details

510(k) Number K023187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2002
Decision Date December 02, 2002
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 382
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K023187.
VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
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K022199 · Endius, Inc. · Oct 2002
ENDIUS FLEXTIP BLADE
K022578 · Endius, Inc. · Aug 2002
ENDIUS ATAVI SYSTEM
K021748 · Endius, Inc. · Jun 2002