510(k) K021019
- Device
- COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
- Applicant
- GENZYME CORP.
- 510(k) number
- K021019
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-18
- Date received
- 2002-03-29
- 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
- MARY GRAY
- Address
- 600 Airport Rd. Fall River MA US 02720 02720
FDA Registration Numbers#
- 3016926753
- 3010667733
- 3008837339
- 1221934
- 3034676720
- 3001592626
- 3006272282
- 3006524618
- 3025603301
- 3014479313
- 3029901632
- 3012103978
- 1320468
- 3013187142
- 1043534
- 1220477
- 3014004349
- 2245304
- 3002719998
- 3007791599
- 2249062
- 3032543753
- 3008114965
- 3009732568
- 3015724777
- 1220246
- 3021008900
- 3016426842
- 3015806723
- 3021226419
- 1066741
- 3017210488
- 3038718579
- 8044102
- 2030624
- 1526012
- 3007791573
- 1219930
- 3011276344
- 3015543569
- 3000215346
- 3012502601
- 2521877
- 3012329552
- 3016904853
- 3010400367
- 1048735
- 3008812241
- 1423537
- 3012883081
- 3024021261
- 3006498370
- 3011683674
- 2320767
- 1043214
- 2246552
- 3016851379
- 3010273872
- 3020954746
- 3014615644
- 2090040
- 2650143
- 3013700547
- 1000484830
- 3009756327
- 3045855232
- 3044819802
- 3002579136
- 3008793310
- 3014286836
- 3018094310
- 3017196117
- 3010146686
- 3011230048
- 3014579161
- 3027339877
- 3045857302
- 3027605742
- 3004549189
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#
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