# K031974: Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0

- Pathway: 510(k) (Traditional)
- Applicant: Asap Endoscopic Products GmbH
- Decided: Sep 29, 2003 after 95 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K770378 (1977). 5 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962256: Galileo Hysteroscopes and Laparoscopes, Galileo Electro-Optics Corp. (1996) Summary page 1.
- K982276: Baho Autoclavable Laparoscope, Microptix Int'L, LLC (1999) Summary page 1.
- (no number) Baho Hysteroscope: named in the summary without a submission number

## Most influential descendants
- K060899: Flexilux II Cystoscope and Hysteroscope (2007), 19 descendants of its own
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (2015), 18 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own
- K183020: Endosee System (2019), 4 descendants of its own

## Indications for use
Hysteroscope: Provides illumination and visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Gynecologic Laparoscope: Used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K031974
Methodology: https://510kreport.com/methodology