TAS Medical, Inc. Tissue Approximation System
The TAS Tissue Approximation System brings soft tissue edges together using a nylon tie with a one-way locking clasp. A braided PET leader helps pass the tie through the tissue. The clasp…
The TAS Tissue Approximation System brings soft tissue edges together using a nylon tie with a one-way locking clasp. A braided PET leader helps pass the tie through the tissue.
The clasp retains the tension set during placement without a surgical knot. The nonabsorbable nylon tie has a rectangular cross-section and remains as the fixation element.
Listed Item
The Tissue Approximation System (TAS) consists of a polyamide (nylon) “zip-tie” attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots. When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.
Kit and Application
A sterile kit contains four ties with integrated leaders and handheld instruments that can assist insertion. Applications include general soft tissue approximation, minimally invasive ventral hernia procedures and abdominal wall closure under 10 cm. The system is not intended for ophthalmic, neurological or cardiovascular procedures.
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | TAS Medical, Inc., United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K220980 |
| Record published | 2024-09-09 |
| Record revised | 2024-04-30 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 37 cm; width 2.7 mm; height 1.4 µm; height 1.4 mm |
| Distribution end date | 2024-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T-5000 | Length 37 cm | In distribution |
| T-LAP | Length 37 cm | In distribution |
| T-4000 | Length 37 cm | In distribution |
| T-LAP | Length 37 cm | Withdrawn |
| T-4000 | Length 37 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLON | Demetech Corp. | 1,800 |
| Dafilon | B Braun Surgical SA | 592 |
| WEGO-Nylon Non-absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 279 |
| Ethilon | Ethicon, Inc. | 272 |
| Monosof | Covidien LP | 256 |
| DemeLON Multi | Demetech Corp. | 227 |
| Surgilon | Covidien LP | 135 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 127 |
| Supramid Extra | S. Jackson, Inc. | 119 |
| Mani Sutures Nylon | Mani, Inc. | 88 |
| Onatec | Surgical Specialties México, S. de R.L. de C.V. | 75 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 73 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261484 | 2026-06-03 |
| K220980 | 2023-07-05 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| TAS Medical, Inc. | 510(k) number | 2025-01-27 | Class II | Device Design | 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 rehyd | 114 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N85060 | 1988-02-22 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. |
| N85316 | 1986-06-20 | ETHILON/NUROLON NYLON SUTURES | Ethicon, Inc. |
| N80838 | 1985-07-23 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. |
| N83511 | 1982-05-18 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.