Novatech SA: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Novatech SA” (first 1997, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 118 days. Since 2017 the median was 68 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 269 |
| 2017 | 1 | 68 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 1 | 184 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Novatech SA took a median 68 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| NWA | Prosthesis, Tracheal, Preformed/Molded | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Review panels
Most recent Novatech SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242324 | DUTAU-NOVATECH® | EOQ | 2025-02-06 | 184 |
| K243126 | TRACHEOBRONXANE DUMON® | NWA | 2024-10-29 | 29 |
| K170030 | NOVATECH TALCAIR | GCJ | 2017-03-13 | 68 |
| K151832 | NOVATECH TALCAIR | GCJ | 2016-03-31 | 269 |
| K971509 | ENDOXANE | NWA | 1997-08-21 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Novatech SA.
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 Novatech SA?
FDA lists 5 510(k) clearances under the applicant name “Novatech SA” (first 1997, latest 2025), across 3 product codes in 3 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 Novatech SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novatech SA is 118 days. Since 2017: 68 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Novatech SA?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); NWA (Prosthesis, Tracheal, Preformed/Molded, 2); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 5 Novatech SA clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Novatech SA'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.