# K982771: Gyrus Hysteroscopic Resectoscope

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Ltd.
- Decided: Jan 21, 1999 after 167 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
53 later devices descend from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COMEG Endoscopy Resectoscope: named in the summary without a submission number
- (no number) Karl Storz Hysteroscopic Resectoscope Models 27040/27050: named in the summary without a submission number

## Most influential descendants
- K990628: Gyrus Endourology System (1999), 52 descendants of its own
- K030194: Xues-41 Endoscopic Electrosurgical Unit (2003), 49 descendants of its own
- K100816: PK Superpulse Sysem Generator Model 744000 (2010), 22 descendants of its own
- K110268: Forcetriad Electrosurgical Generator (2011), 16 descendants of its own
- K994166: Gyrus Endourology System: Axipolar Resectoscope Electrode (1999), 16 descendants of its own

## Indications for use
Used to permit direct viewing and access to the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. As used with the Gynecare Versapoint System, the indications for use include: Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa

Source page: https://510kreport.com/device/K982771
Methodology: https://510kreport.com/methodology