510(k) K253024
- Device
- ProZip Knotless Implant
- Applicant
- Riverpoint Medical
- 510(k) number
- K253024
- Product code
- GAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-16
- Date received
- 2025-09-19
- Regulation
- 878.5000
- Classification name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Bianca Silva de Sousa
- Address
- 825 NE 25th Ave. Portland OR US 97232 97232
FDA Registration Numbers#
- 3043620689
- 3009018440
- 1721676
- 3029754081
- 3027339877
- 3010692967
- 3013302242
- 3006946276
- 3010047454
- 3022518322
- 3013298431
- 3014579161
- 1220246
- 1718850
- 3030655570
- 3034676720
- 1320894
- 3010864832
- 3010667733
- 3027605742
- 3006498370
- 3014461810
- 9611459
- 3011230048
- 3014479313
- 2210968
- 1045254
- 3004215117
- 3004060107
- 2936485
- 3020704423
- 3015173212
- 1221934
- 3021226419
- 3015724777
- 3012329552
- 3020954746
- 3025603301
- 3003477135
- 1066741
- 3014615644
- 3012883081
- 3027242374
- 1221601
- 1064017
- 3003639970
- 3009423112
- 3010163695
- 3004117249
- 1043534
- 3010400367
- 3008812241
- 3020899789
- 2024311
- 3021190802
- 3020983460
- 2528981
- 3032543753
- 3016926753
- 1055236
- 2521877
- 3005953126
- 9616088
- 3013548553
- 3021393544
- 3038718579
- 3007319107
- 3006630150
- 3005064037
- 3017636737
- 1064584
- 3007791573
- 9616062
- 3013767421
- 3005160949
- 3038503932
- 2530154
- 3045857302
- 1061124
- 3006524618
Source Documents#
Other 510(k) Records For Product Code GAT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | 2026-08-22 |
| 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 |
| 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 |