# K990397: Flexible Fiberscopes & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Oct 25, 1999 after 258 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946087 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962172: Flexible Mini-Fiberscopes, Richard Wolf Medical Instruments Corp. (1996) Summary page 6.
- K971455: Clarus Model 5197 Sightlite, Clarus Medical Systems, Inc. (1997) Summary page 6.
- K946087: Inclusice II (TM) Endoscope, Sofamor Danek USA,Inc. (1995) Summary page 6.
- (no number) LASE Flexible Endoscope: named in the summary without a submission number

## Indications for use
Flexible Fiberscope: For examination, diagnosis, and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in lumbar spine applications. Flexible Biopsy Forcep: Used to obtain small biopsies from tissue Electrodes: Used for unipolar coagulation. Field of Application: The instruments are designed to be used by adequately trained and qualified medical personnel in the fields of spine, urology, surgery, gynecology, and ENT. IMPORTANT! The product dimensions must correspond with the anatomic proportions, ie; the correct flexible fiberscope must be selected for the medical procedure.

Source page: https://510kreport.com/device/K990397
Methodology: https://510kreport.com/methodology