# K031972: Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,

- Pathway: 510(k) (Traditional)
- Applicant: Asap Endoscopic Products GmbH
- Decided: Sep 15, 2003 after 81 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 K962330 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962330: Amo Arthoscopes, American Microptiks, Inc. (1996) Summary page 1.

## Most influential descendants
- K070021: Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 (2007), 1 descendant of its own
- K163037: Intra medullary endo-transilluminating device (iMET device) (2017), 0 descendants of its own

## Indications for use
The asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal-mandibular Joint, ankle and elbow. The asap arthroscope is reusable and has to be sterilized prior to each procedure by the user. The intended use for the asap arthroscope is according to relevant medical indication by trained physicians only.

Source page: https://510kreport.com/device/K031972
Methodology: https://510kreport.com/methodology