Tissuelink Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Tissuelink Medical, Inc.” (first 2000, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 12 | 12 |
Review panels
Most recent Tissuelink Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073495 | TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT | GEI | 2008-01-09 | 28 |
| K063639 | AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 | GEI | 2007-02-22 | 77 |
| K052859 | AQUAMANTYS PUMP GENERATOR SYSTEM | GEI | 2005-10-25 | 14 |
| K032132 | TISSUELINK FLOATING BALL MODEL 23-201-1 | GEI | 2003-08-20 | 40 |
| K030380 | TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1 | GEI | 2003-03-03 | 26 |
| K022532 | TISSUELINK BIPOLAR FLOATING BALL DEVICE | GEI | 2003-02-12 | 196 |
| K020574 | TISSUELINK BIPOLAR FLOATING BALL DEVICE | GEI | 2002-05-20 | 88 |
| K014260 | TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE | GEI | 2002-03-27 | 90 |
| K010661 | MODIFICATION TO TISSUELINK BIPOLAR FORCEPS | GEI | 2001-05-03 | 63 |
| K010662 | MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL | GEI | 2001-04-27 | 57 |
2 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2005-02-07.
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 Tissuelink Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Tissuelink Medical, Inc.” (first 2000, latest 2008), 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 Tissuelink Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tissuelink Medical, Inc. is 68 days.
Which FDA product codes appear under Tissuelink Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 12).
Next steps
- See all 12 Tissuelink Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Tissuelink Medical, 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, 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.