# K992544: Transvaginal Hydro Laparoscopy (THL) System

- Pathway: 510(k) (Traditional)
- Applicant: Circon Corp.
- Decided: Oct 26, 1999 after 88 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- 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 K980972 (1998). 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)
- K980972: Rigid Culdoscope and Accessories, Circon Corp. (1998) Summary page 1.
- (no number) ACMI Decker Operating Culdoscope and accessories: named in the summary without a submission number

## Indications for use
Circon’s Rigid Operative Culdoscopy Accessories are intended to be used with Circon’s Rigid Culdoscope and Accessories for viewing pelvic organs endoscopically via a posterior vaginal fornix entry for the purpose of performing diagnostic and operative procedures on the female genital organs. Indications for use are: Unexplained pelvic pain (acute, chronic) Menstrual abnormalities Infertility and sterility Indefinite pelvic mass Ectopic pregnancy Pelvic endometriosis Polycystic ovaries Pelvic inflammatory disease (PID) Pain mapping Congenital anomalies of the pelvic organs Lysis of adhesions Cytology sampling Biopsy

Source page: https://510kreport.com/device/K992544
Methodology: https://510kreport.com/methodology