# K993749: Gyrus Hysteroscopic Resectoscope

- Pathway: 510(k) (Special)
- Applicant: Gyrus Medical, Ltd.
- Decided: Dec 3, 1999 after 28 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
Longest line of descent: 1 generation back to K971881 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971881: Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors, Comeg Endoscopy (1997). Our OCR of the scanned summary read K971882, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “COMEG Endoscopy Resectoscope”.

## Indications for use
Used to permit direct viewing of 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 on intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa When used for resection of endometrial tissue with the G-VAP Electrode, the device is indicated for Endometrial Ablation.

Source page: https://510kreport.com/device/K993749
Methodology: https://510kreport.com/methodology