Data / Medical devices / United States / Tas Medical, Inc.
Tas Medical, Inc.: FDA-registered device maker in Windermere, FL, United States, 2 510(k) clearances
Tas Medical, Inc. is registered with the FDA (registration 3029835193) in Windermere, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 3, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3029835193
- Address
- 9100 Conroy Windermere Rd Suite 200, Windermere, FL, United States, 34786
- Owner or operator
- TAS Medical, Inc. (10089073)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 3, 2023
- Registered through
- 2026
- Brand names listed
- TAS Tissue Approximation System, Tissue Approximation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2026 | K261484 | Tissue Approximation System | GAR | Substantially Equivalent | Tas Medical, Inc. | accessdata.fda.gov |
| July 5, 2023 | K220980 | Tissue Approximation System (TAS) | GAR | Substantially Equivalent | Tas Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 27, 2025 | 96274 | Class II | Ongoing | TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP | Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F sterile saline solution for 60 min prior to implantation to rehydrate the zip-tie straps. Broken zip-ties not observed during procedure could lead to future hernia recurrence, recurrent | accessdata.fda.gov |
Compare with other makers
Updated June 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.