Tissue Technologies, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Tissue Technologies, Inc.” (first 1995, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 6 | 6 |
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
Review panels
Most recent Tissue Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002071 | SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES | FTL | 2000-07-24 | 17 |
| K000849 | SOFTFORM FACIAL IMPLANT | FTL | 2000-05-19 | 65 |
| K982475 | SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL | FTL | 1998-09-22 | 68 |
| K973462 | SOFTFORM FACIAL IMPLANT | FTL | 1997-11-24 | 73 |
| K970804 | TRU-PULSE CO2 SURGICAL LASER | GEX | 1997-06-03 | 91 |
| K963683 | TRU-PULSE LASER (MODIFIED) | GEX | 1997-02-12 | 167 |
| K962496 | SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) | FTL | 1996-09-03 | 69 |
| K960481 | SOFT TISSUE AUGMENTATION TUBE | FTL | 1996-04-01 | 59 |
| K952049 | TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM | GEX | 1995-07-21 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Tissue Technologies, 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.
- Tissue Culture Innovations (6 510(k)s)
- Tissue Science Laboratories, Plc (6 510(k)s)
- Tissue Regeneration Technologies, LLC (5 510(k)s)
- Tissue Technologies Holdings, LLC (2 510(k)s)
- Tissue Culture Biologicals (1 510(k)s)
- Tissue Culture Biotec, Inc. (1 510(k)s)
- Tissue Differentiation Intelligence, LLC (1 510(k)s)
- Tissue Medical Lasers, Inc. (1 510(k)s)
- Tissue Regeneration Systems, Inc. (1 510(k)s)
- Tissue Regeneration Technologies, LLC Dba AS Softwave Trt (1 510(k)s)
- Tissue Regenix Group Plc (1 510(k)s)
- Tissue Repair Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tissue Technologies, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Tissue Technologies, Inc.” (first 1995, latest 2000), across 2 product codes 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 Tissue Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tissue Technologies, Inc. is 69 days.
Which FDA product codes appear under Tissue Technologies, Inc.?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 6); GEX (Powered Laser Surgical Instrument, 3).
Next steps
- See all 9 Tissue Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTL, Tissue Technologies, 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.