Data / Medical devices / Germany / asap endoscopic products GmbH
asap endoscopic products GmbH: FDA-registered device maker in Umkirch Baden-Wurttemberg, Germany, 5 510(k) clearances
asap endoscopic products GmbH is registered with the FDA (registration 3008494403) in Umkirch Baden-Wurttemberg, Germany. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 8, 2013. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008494403
- Address
- Stoeckmatten19, Umkirch Baden-Wurttemberg, Germany, 79224
- Owner or operator
- asap GmbH (10023512)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- Hysteroscopes, Multifunction Video/Motionsystem, Multiscopes, Otoscope ENT, TV-Adapter, asap Arthroscope, asap Cystoscope, asap Hysteroscope and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | 1 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Television, Endoscopic, Without Audio | FWF | 1 | Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 8, 2013 | K121261 | ASAP MUITISCOPE | HRX | Substantially Equivalent | Asap Endoscopic Products GmbH | accessdata.fda.gov |
| January 8, 2004 | K032822 | ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0 | EOB | Substantially Equivalent | Asap Endoscopic Products GmbH | accessdata.fda.gov |
| September 29, 2003 | K031974 | ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 | HIH | Substantially Equivalent | Asap Endoscopic Products GmbH | accessdata.fda.gov |
| September 15, 2003 | 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, | HRX | Substantially Equivalent | Asap Endoscopic Products GmbH | accessdata.fda.gov |
| June 30, 2003 | K031141 | ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE | FAJ | Substantially Equivalent | Asap Endoscopic Products GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Hysteroscope (And Accessories)
- All makers of Camera, Television, Endoscopic, Without Audio
- All makers of Accessories, Photographic, For Endoscope (Exclude Light Sources)
- All makers of Otoscope
- All makers of Nasopharyngoscope (Flexible Or Rigid)
- All makers of Laparoscope, Gynecologic (And Accessories)
Updated January 8, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.