PRONOVA NONABSORBABLE SUTURE, USP
FDA 510(k) clearance K001625 · decided 2000-07-10
Clearance details
- K-number
- K001625
- Device name
- PRONOVA NONABSORBABLE SUTURE, USP
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-17
- Decision date
- 2000-07-10
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- GAW
- Device class
- 2
- Regulation number
- 878.5010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device (K253572) | ETHICON, Inc. | 2026-03-27 |
| Cypris eXact Suturing System (K233355) | Cypris Medical | 2024-01-12 |
| Non absorbable Surgical Polypropylene Suture (K230746) | Shandong Haidike Medical Products Co., Ltd. | 2023-09-14 |
| Vesseal (K221280) | Lydus Medical , Ltd. | 2022-12-09 |
| DURAMESH Mesh Suture (K211178) | Msi | 2022-09-02 |
| APTOS Threads – Polypropylene Surgical Sutures (K192953) | Aptos, LLC | 2020-08-27 |
| Deklene MAXX (K193530) | Teleflex Medical | 2020-03-19 |
| Silhouette Featherlift / Silhouette Lift (K191299) | Silhouette Lift, Inc. | 2019-06-14 |
| REXLENE (K173747) | Sm Eng Co., Ltd. | 2018-12-21 |
| Aesculap Optilene Nonabsorbable Suture (K180321) | Aesculap, Inc. | 2018-03-07 |
| Gazelle Polypropylene Suture and Delivery Device (K173644) | Dura Tap, LLC | 2018-02-15 |
| Assut Filbloc Permanent Sutures (K171039) | Assut Europe S.P.A. | 2017-08-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |