DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
FDA 510(k) clearance K903643 · decided 1990-12-24
Clearance details
- K-number
- K903643
- Device name
- DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
- Applicant
- Deknatel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-10
- Decision date
- 1990-12-24
- Days to decision
- 136 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
- San Jose-Heredia, CR
- Third-party review
- No
- Expedited review
- No
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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 |
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| 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 |
|---|---|---|
| NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S006) | Deknatel, Inc. | 1989-06-16 |
| NONABSORBABLE SURG. SUTURES, NYLON (N85060/S007) | Deknatel, Inc. | 1989-06-16 |
| DEKLENE(TM) (P810028/S011) | Deknatel, Inc. | 1989-06-16 |
| DEKLENE(TM) (P810028/S010) | Deknatel, Inc. | 1989-02-02 |
| NONABSORBABLE SURG. SUTURES, NYLON (N85060/S005) | Deknatel, Inc. | 1989-01-31 |
| DEKLENE(TM) (P810028/S008) | Deknatel, Inc. | 1989-01-31 |
| CHROMIC GUT SUTURE (N84381/S007) | Deknatel, Inc. | 1989-01-31 |
| NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S004) | Deknatel, Inc. | 1989-01-31 |