510(k) K001434
- Device
- 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
- Applicant
- GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
- 510(k) number
- K001434
- Product code
- GAT
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 2000-06-12
- Date received
- 2000-05-08
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY E GRAY
- Address
- 600 Airport Rd. Fall River MA US 02720 02720
FDA Registration Numbers#
- 3014262693
- 3001592626
- 3015183635
- 3016678045
- 3036756245
- 1064017
- 3004117249
- 3008793310
- 3014461810
- 3010400367
- 3021226419
- 3020899789
- 1526012
- 3034676720
- 3004944585
- 3014479313
- 3027339877
- 3012818475
- 3004447686
- 3015539532
- 3002719998
- 3021632375
- 3003639970
- 3017210488
- 3015173212
- 3005381997
- 1066741
- 3015724777
- 3017102971
- 1417592
- 1718850
- 1226146
- 1043534
- 1055236
- 1423537
- 2249062
- 3027605742
- 3030655570
- 3007205024
- 3005160949
- 3004549189
- 3013302242
- 2530154
- 3015543569
- 3016926753
- 3006108336
- 3003477135
- 3012103978
- 3021008900
- 3020954746
- 2183301
- 3016851379
- 2031093
- 3006638824
- 2032098
- 1064584
- 3015207155
- 2030598
- 3010047454
- 3009423112
- 3044819802
- 3013403214
- 3000215346
- 3006498370
- 3002579136
- 2090040
- 1000484830
- 3019269298
- 3029754081
- 3011230048
- 3010864832
- 3015542154
- 3003267729
- 1045254
- 3011989923
- 3005180920
- 3009513193
- 2648623
- 9611459
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases