# K990004: Dci Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Apr 2, 1999 after 88 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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
This instrament is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures. Specific Indications for Use unexplained pelvic pain (acute, chronic) infertility work-up tubal sterilization unexplained primary or secondary amenorrhea diagnosis and/or treatment of ectopic pregnancy evaluation, diagnosis and/or treatment of small pelvic tumors, including myomata evaluation of congenital anomalies of the pelvic organs retrieval of foreign bodies determination of the presence and extent of pelvic endometriosis determination of the presence and extent of pelvic inflammatory disease laparoscopic assisted vaginal hysterectomy visualization, diagnasis and/or treatment of perforate abdominal organs

Source page: https://510kreport.com/device/K990004
Methodology: https://510kreport.com/methodology