# K980302: Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jul 20, 1998 after 174 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895857 (1990). 2 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895857: Continuous Irrigation Resectoscope Syst/Gynecology, Richard Wolf Medical Instruments Corp. (1990) Summary page 1.
- K953983: Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue, Richard Wolf Medical Instruments Corp. (1996) Summary page 1.
- (no number) USA Elite System Resectoscopes: named in the summary without a submission number
- (no number) Resectoscopes 27040-27050, 27143: named in the summary without a submission number

## Most influential descendants
- K011496: Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and Forceps Model 8650, 8652, 8660 (2001), 12 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own

## Recalls of this device
- May 23, 2019 · Class II · Z-1957-2019: E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.

## Indications for use
Intended Use. Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and / or therapy in various medical disciplines, such as urology and gynecology.

Source page: https://510kreport.com/device/K980302
Methodology: https://510kreport.com/methodology