510(k) K220980
- Device
- Tissue Approximation System (TAS)
- Applicant
- Tas Medical, Inc.
- 510(k) number
- K220980
- Product code
- GAR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-05
- Date received
- 2022-04-04
- Regulation
- 878.5020
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Tozzi
- Address
- 1100 Industrial Rd. San Carlos CA US 94070 94070
FDA Registration Numbers#
- 1111225
- 1423537
- 3006425876
- 3006981798
- 3015330532
- 2244478
- 1064514
- 1062668
- 3003639970
- 3014117096
- 3013002341
- 2648623
- 3022766613
- 3017196117
- 9616088
- 3018094310
- 1930126
- 3020983460
- 1054241
- 3006562124
- 2245304
- 9611459
- 3004117249
- 3018052045
- 3003915875
- 3004192065
- 3007791573
- 1018470
- 9710098
- 3017636737
- 1000274611
- 1219930
- 3015183635
- 3016426842
- 3014592276
- 3017102971
- 9611484
- 3013403214
- 3038718579
- 1055236
- 1221601
- 3004111573
- 3003267729
- 3010864832
- 3010692967
- 2521877
- 3009513193
- 3010162973
- 1061124
- 3014273254
- 1221051
- 1017294
- 3004365956
- 3004060107
- 3013187142
- 1226146
- 3029901632
- 3030733800
- 3007205024
- 3016904853
- 1043214
- 2320762
- 3012101664
- 3004215117
- 2246552
- 2210968
- 3011560638
- 3010452421
- 1054811
- 3013298431
- 2648650
- 3004845555
- 2183301
- 9612501
- 3010131137
- 2523835
- 1064584
- 3012494290
- 3014461810
Source Documents#
Other 510(k) Records For Product Code GAR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | 2022-03-31 |
| K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 |
| K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020-05-29 |
| K161633 | REXLON, REXSIL | Sm Eng Co., Ltd. | 2017-03-02 |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016-02-17 |
| K152795 | RiverLon (Nylon) Suture | Riverpoint Medical | 2015-10-28 |
| K123034 | VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED | Unilene Sac | 2013-05-28 |
| K081366 | KUMAR T-ANCHORS HERNIA SET | Nashville Surgical Instruments | 2008-07-15 |
| K060471 | FSSB NYLON SURGICAL SUTURES | Fssb Chirurgische Nadeln GmbH | 2006-07-26 |
| K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | Mani, Inc. | 2006-05-19 |
| K060528 | AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE | Aesculap, Inc. | 2006-03-28 |
| K052900 | QUILL NONABSORBABLE NYLON BARBED SUTURE | Quill Medical, Inc. | 2005-11-28 |
| K052482 | ARTELON SURGICAL SUTURE | Artimplant AB | 2005-10-17 |
| K041510 | TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE | Sutures India Private Limited | 2005-06-02 |
| K042284 | UNIMIDE | United Medical Industries Co. , Ltd. | 2004-12-03 |