# K031141: Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope

- Pathway: 510(k) (Traditional)
- Applicant: Asap Endoscopic Products GmbH
- Decided: Jun 30, 2003 after 81 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963426 (1996). 3 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992983: Baho Autoclavable Cystoscope, Innovative Endoscopy Components, LLC (1999) Summary page 1.
- K993688: Aed Laparoscope, National Advanced Endoscopy Devices, Inc. (1999) Summary page 1.
- K963426: Karl Storz Contact Micro-Laryngoscopes, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 1.
- (no number) Baho Esophagoscope: 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
Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.

Source page: https://510kreport.com/device/K031141
Methodology: https://510kreport.com/methodology