Guenter Bissinger Medizintechnik GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Guenter Bissinger Medizintechnik GmbH” (first 1998, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 76 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 | 1 | 44 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 421 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guenter Bissinger Medizintechnik GmbH took a median 421 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Review panels
Most recent Guenter Bissinger Medizintechnik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213042 | Supra Non-Stick Bipolar Forceps | GEI | 2022-11-17 | 421 |
| K150024 | Bissinger Monopolar Cables | GEI | 2015-02-20 | 44 |
| K051429 | CLARIS NON-STICK BIPOLAR FORCEPS | GEI | 2005-07-29 | 58 |
| K042077 | BITECH BIPOLAR SCISSORS | GEI | 2004-10-27 | 86 |
| K981919 | BISSINGER CABLES, CAT. NO. 801000XX | GEI | 1998-08-06 | 66 |
| K970968 | BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS | HET | 1998-05-21 | 430 |
Recalls
openFDA lists no recalls under a recalling firm named Guenter Bissinger Medizintechnik 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Guenter Bissinger Medizintechnik GmbH?
FDA lists 6 510(k) clearances under the applicant name “Guenter Bissinger Medizintechnik GmbH” (first 1998, latest 2022), across 2 product codes in 2 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 Guenter Bissinger Medizintechnik GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guenter Bissinger Medizintechnik GmbH is 76 days.
Which FDA product codes appear under Guenter Bissinger Medizintechnik GmbH?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 6 Guenter Bissinger Medizintechnik GmbH clearances with predicates and recalls
- Run predicate analysis for product code GEI, Guenter Bissinger Medizintechnik 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.