Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh” (first 1995, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 207 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 | 0 | — |
| 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 6 | 6 |
| HIF | Insufflator, Laparoscopic | 3 | 3 |
Review panels
Most recent Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031014 | HI-FLO THERME PNEU 45, WISAP #7083, 7083V | HIF | 2003-06-27 | 88 |
| K011510 | MULTI HI-FLO PNEU, WISAP #7080 | HIF | 2002-04-02 | 321 |
| K992513 | THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF | HET | 2000-03-17 | 235 |
| K992481 | CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF | HET | 2000-03-17 | 235 |
| K990662 | DISPOSABLE HEATING TUBING SET #7642HSES | HIF | 1999-09-24 | 207 |
| K982515 | POWER-DRIVE, WISAP MODEL #7688PD/7688PD1 | HET | 1999-01-19 | 183 |
| K982518 | AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608 | HET | 1999-01-14 | 178 |
| K960640 | S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) | HET | 1997-02-14 | 368 |
| K952508 | FLOW-THERME, WISAP #7642 | HET | 1995-08-25 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh?
FDA lists 9 510(k) clearances under the applicant name “Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh” (first 1995, latest 2003), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh is 207 days.
Which FDA product codes appear under Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh?
The most frequent FDA product codes under this applicant name are HET (Laparoscope, Gynecologic (And Accessories), 6); HIF (Insufflator, Laparoscopic, 3).
Next steps
- See all 9 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh clearances with predicates and recalls
- Run predicate analysis for product code HET, Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh'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.