510(k) K060721
- Device
- LARIAT LOOP APPLICATOR
- Applicant
- SENTREHEART
- 510(k) number
- K060721
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-02
- Date received
- 2006-03-17
- Regulation
- 878.5000
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- 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
- ROBERT CHIN
- Address
- 2468 Embarcadero Way Palo Alto CA US 94303 94303
FDA Registration Numbers#
- 3003755939
- 3015231789
- 3012883081
- 3021336182
- 3014276972
- 1221601
- 1319660
- 3004447686
- 1048735
- 3007663067
- 2648666
- 2530154
- 3030655570
- 3011689956
- 3001592626
- 3035366890
- 3013298431
- 3013302242
- 3008868758
- 1017294
- 2028632
- 2648623
- 9616088
- 3007791573
- 1643264
- 3003139373
- 2031093
- 3002719998
- 1721676
- 2183301
- 3038503932
- 2246552
- 3013187142
- 3027242374
- 3010060157
- 3008114965
- 1054811
- 3045855232
- 3014262693
- 3005381997
- 1064017
- 3006498370
- 3010452421
- 3007791599
- 3022518322
- 9616062
- 3013403214
- 3011706110
- 3009380063
- 3045857302
- 1043214
- 1018470
- 3017196117
- 3010162973
- 3009672666
- 3014004349
- 1066741
- 3006562124
- 1221051
- 3027454646
- 3002807315
- 3009423112
- 3012329552
- 3027605742
- 2648650
- 3021349259
- 2528981
- 1423537
- 3015539532
- 1320468
- 9610622
- 3006946276
- 2032098
- 3018052045
- 3010047454
- 3020983460
- 3021393544
- 3010273872
- 2011171
Source Documents#
Other 510(k) Records For Product Code GAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261021 | EasyWhip Family | Winter Innovations, Inc. | 2026-07-01 |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | Teleflex Medical, LLC | 2026-05-06 |
| K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | 2026-03-23 |
| K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 |
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 2025-10-22 |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 2025-10-16 |
| K252225 | PowerKnot High Strength Sutures | Medacta International S.A. | 2025-09-12 |
| K252201 | HS Fiber | Riverpoint Medical | 2025-08-13 |
| K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025-03-27 |
| K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | 2024-08-09 |
| K234079 | HyperSuture Extension Line | Threadstone, LLC | 2024-05-10 |
| K231163 | HS Fiber Sutures | Riverpoint Medical | 2024-01-05 |
| K230311 | HyperSuture | Threadstone, LLC | 2023-11-24 |
| K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023-08-25 |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical , Ltd. | 2023-08-10 |
Legacy Summary#
summary
FDA Review#
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