Sulzer Intratherapeutics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Sulzer Intratherapeutics, Inc.” (first 2001, latest 2002), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 | 7 |
| JCT | Prosthesis, Tracheal, Expandable | 1 | 1 |
Review panels
Most recent Sulzer Intratherapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023243 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | FGE | 2002-12-13 | 74 |
| K021729 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | FGE | 2002-06-21 | 28 |
| K021563 | INTRACOIL SELF-EXPANDING PERIPHERAL STENT | JCT | 2002-05-31 | 18 |
| K020528 | INTRASTENT LD (LARGE DIAMETER) STENT | FGE | 2002-04-16 | 56 |
| K014136 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | FGE | 2002-01-17 | 31 |
| K011806 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | FGE | 2001-09-07 | 88 |
| K012347 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | FGE | 2001-08-23 | 30 |
| K012066 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | FGE | 2001-08-01 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Sulzer Intratherapeutics, Inc..
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.
- Sulzer Orthopedics, Inc. (45 510(k)s)
- Sulzer Calcitek, Inc. (9 510(k)s)
- Sulzer Dental, Inc. (9 510(k)s)
- Sulzer Carbomedics, Inc. (8 510(k)s)
- Sulzer Spine-Tech (7 510(k)s)
- Sulzer Oscor, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sulzer Intratherapeutics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Sulzer Intratherapeutics, Inc.” (first 2001, latest 2002), 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 Sulzer Intratherapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sulzer Intratherapeutics, Inc. is 30 days.
Which FDA product codes appear under Sulzer Intratherapeutics, Inc.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 7); JCT (Prosthesis, Tracheal, Expandable, 1).
Next steps
- See all 8 Sulzer Intratherapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Sulzer Intratherapeutics, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.