Cleared Traditional

K945891 - KARL STORZ KNIVES, CURETTS, HOOKS, PROBES

K945891 is an FDA 510(k) clearance for KARL STORZ KNIVES, 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 190-day FDA review.

K945891 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
190d
Days
Class 2
Risk

K945891 is an FDA 510(k) clearance for the KARL STORZ KNIVES, CURETTS, HOOKS, PROBES. 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 June 9, 1995 after a review of 190 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

FDA 510(k) Submission Details - K945891

510(k) Number K945891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date June 09, 1995
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
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 K945891.
OLYMPUS ARTHROSCOPY SYSTEM
K951354 · Olympus America, Inc. · Jun 1995
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES
K945787 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
ACUFEX PATELLAR BONE BLOCK SIZER
K944500 · Acufex Microsurgical, Inc. · Jun 1995
ACUFEX ENDOBUTTON PACK
K951859 · Acufex Microsurgical, Inc. · Jun 1995
KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES
K952192 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
DAVOL ARTHRO-FLO 3
K951026 · Davol Inc., Sub. C. R. Bard, Inc. · Jun 1995