Asap Endoscopic Products GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Asap Endoscopic Products GmbH” (first 2003, latest 2013), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 95 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 257 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRX | Arthroscope | 2 | 2 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Review panels
Most recent Asap Endoscopic Products GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121261 | ASAP MUITISCOPE | HRX | 2013-01-08 | 257 |
| 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 | 2004-01-08 | 120 |
| K031974 | ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0 | HIH | 2003-09-29 | 95 |
| 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 | 2003-09-15 | 81 |
| K031141 | ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE | FAJ | 2003-06-30 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Asap Endoscopic Products GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Asap Dental Lab, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Asap Endoscopic Products GmbH?
FDA lists 5 510(k) clearances under the applicant name “Asap Endoscopic Products GmbH” (first 2003, latest 2013), across 4 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Asap Endoscopic Products GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Asap Endoscopic Products GmbH is 95 days.
Which FDA product codes appear under Asap Endoscopic Products GmbH?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 2); EOB (Nasopharyngoscope (Flexible Or Rigid), 1); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 5 Asap Endoscopic Products GmbH clearances with predicates and recalls
- Run predicate analysis for product code HRX, Asap Endoscopic Products GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.