510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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TAS Medical Inc

Windermere, FL, US

TAS MEDICAL, INC. appears in FDA device records in Windermere, FL. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for TAS Medical Inc between 2023 and 2026. The busiest year on record is 2023, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for TAS Medical Inc, by decision year
YearClearances
20231
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261484Tissue Approximation SystemGARSubstantially Equivalent
K220980Tissue Approximation System (TAS)GARSubstantially Equivalent

Registered establishments

FDA registered establishments for TAS Medical Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30298351933029835193TAS MEDICAL, INC.9100 Conroy Windermere Rd, Windermere, FL 34786 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1294-2025TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAPTissue 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 surgery to correct a large herniation.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain