# K993804: Ksea Rigid Culdoscope and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Feb 7, 2000 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The KSEA Rigid Culdoscope and Accessories is intended for use by qualified surgeons for viewing the organs within the peritoneal cavity, via a posterior vaginal fornix entry, using CO, gas insufflation, This Culdoscope is not intended for transvaginal hydrolaparoscopy (transflotation). This Culdoscope has the following diagnostic indications: 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/K993804
Methodology: https://510kreport.com/methodology