# K033728: Transvaginal Endoscopy Set

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Feb 27, 2004 after 91 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 TVE Set is indicated for use by qualified surgeons during outpatient or clinical endoscopic examination of the female genital tract. This examination method is designed to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, illow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures. 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 abnormalities of the pelvic organs; * Lysis of adhesions; * Cytology mapping; * Biopsy.

Source page: https://510kreport.com/device/K033728
Methodology: https://510kreport.com/methodology