asap endoscopic products GmbH
Umkirch Baden-Wurttemberg, DE
asap endoscopic products GmbH appears in FDA device records in Umkirch Baden-Wurttemberg, DE. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for asap endoscopic products GmbH between 2003 and 2013. The busiest year on record is 2003, with 3. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 3 |
| 2004 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121261 | ASAP MUITISCOPE | HRX | Substantially Equivalent | |
| 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 | |
| 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 | |
| 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 | |
| K031141 | ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE | FAJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008494403 | 3008494403 | asap endoscopic products GmbH | Stoeckmatten19, Umkirch Baden-Wurttemberg 79224 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- HRXArthroscope
- FWFCamera, Television, Endoscopic, Without Audio
- FAJCystoscope And Accessories, Flexible/Rigid
- HIHHysteroscope (And Accessories)
- HETLaparoscope, Gynecologic (And Accessories)
- EOBNasopharyngoscope (Flexible Or Rigid)
- ERAOtoscope
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain