Sutter Medizintechnik GmbH: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sutter Medizintechnik GmbH” (first 2008, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 106 days. Since 2017 the median was 84 days, against 112 days for all cleared 510(k)s in the same product codes. 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 | 134 |
| 2014 | 0 | — |
| 2015 | 1 | 153 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 246 |
| 2019 | 2 | 60 |
| 2020 | 1 | 49 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 106 |
| 2025 | 0 | — |
| 2026 | 1 | 243 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sutter Medizintechnik GmbH took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 9 | 9 |
Review panels
Most recent Sutter Medizintechnik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251813 | CURIS II RF Generator (REF 360100-05) | GEI | 2026-02-11 | 243 |
| K233425 | FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) | GEI | 2024-01-25 | 106 |
| K193587 | Sutter Swyng non-stick bipolar forceps, single-use | GEI | 2020-02-10 | 49 |
| K192128 | Sutter Arrowtip Monopolar Electrodes | GEI | 2019-10-04 | 58 |
| K191732 | Sutter RaVoR Bipolar Electrodes | GEI | 2019-08-30 | 63 |
| K171869 | Sutter CURIS RF Generator | GEI | 2018-02-23 | 246 |
| K150959 | Sutter Bipolar Forceps-Calvian | GEI | 2015-09-10 | 153 |
| K131012 | SUTTER BIPOLAR FORCEPS - SUPERGLISS | GEI | 2013-08-23 | 134 |
| K073450 | SUTTER ELECTROSURGICAL CABLES | GEI | 2008-03-17 | 98 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-06-23.
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.
- Sutter Biomedical, Inc. (11 510(k)s)
- Sutter Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sutter Medizintechnik GmbH?
FDA lists 9 510(k) clearances under the applicant name “Sutter Medizintechnik GmbH” (first 2008, latest 2026), across 1 product code 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 Sutter Medizintechnik GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sutter Medizintechnik GmbH is 106 days. Since 2017: 84 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sutter Medizintechnik GmbH?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 9).
Next steps
- See all 9 Sutter Medizintechnik GmbH clearances with predicates and recalls
- Run predicate analysis for product code GEI, Sutter 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.