# K980972: Rigid Culdoscope and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Circon Corp.
- Decided: Jun 12, 1998 after 88 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) ACMI’s Decker Culdoscope: named in the summary without a submission number
- (no number) ACMI’s Decker Operating Culdoscope: named in the summary without a submission number
- (no number) Karl Storz Endoscopy America, Inc.’s Culdoscopes: named in the summary without a submission number
- (no number) Richard Wolf Medical Instrument Corp.’s Fiber Light Culdoscopes: named in the summary without a submission number

## Most influential descendants
- K992544: Transvaginal Hydro Laparoscopy (THL) System (1999), 0 descendants of its own

## Indications for use
Circon’s Rigid Culdoscopes and Accessories are intended for viewing pelvic oigans endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for: Unexplained pelvic pain (acute, chronic) Menstrual abnormalities Infertility and sterility Indefinite pelvic mass Ectopic pregnancy Pelvic endometriosis Polycystic ovaries Pelvic inflammatory disease Pain mapping Congenital anomalies of the pelvic organs

Source page: https://510kreport.com/device/K980972
Methodology: https://510kreport.com/methodology