Cleared Traditional

K990397 - FLEXIBLE FIBERSCOPES & ACCESSORIES

K990397 is an FDA 510(k) clearance for FLEXIBLE FIBERSCOPES & ACCESSORIES, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K990397 · Richard Wolf Medical Instruments Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
258d
Days
Class 2
Risk

K990397 is an FDA 510(k) clearance for the FLEXIBLE FIBERSCOPES & ACCESSORIES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 258 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K990397

510(k) Number K990397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1999
Decision Date October 25, 1999
Days to Decision 258 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
136d slower than avg
Panel avg: 122d · This submission: 258d
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 521
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K990397.
METRX SYSTEM
K993021 · Surgical Navigation Technologies, Inc. · Nov 1999
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
K992621 · Advanced Diagnostics & Interventions · Nov 1999
MASS (MICRO-ACCESS SPINE SYSTEM)
K992583 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · Oct 1999
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
K993009 · Hydrocision, Inc. · Oct 1999
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
K990324 · Nuvasive, Inc. · Oct 1999
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
K992782 · Nuvasive, Inc. · Oct 1999