SURGILENE(R) SUTURES
FDA 510(k) clearance K945701 · decided 1995-01-24
Clearance details
- K-number
- K945701
- Device name
- SURGILENE(R) SUTURES
- Applicant
- Davis & Geck, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-11-09
- Decision date
- 1995-01-24
- Days to decision
- 76 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
- Danbury, CT, 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 |
|---|---|---|
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008) | Davis & Geck, Inc. | 1996-11-15 |
| MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S007) | Davis & Geck, Inc. | 1996-01-11 |
| NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE (P840041/S006) | Davis & Geck, Inc. | 1996-01-11 |
| NOVAFIL(TM) (P840041/S005) | Davis & Geck, Inc. | 1994-04-20 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S006) | Davis & Geck, Inc. | 1992-03-24 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005) | Davis & Geck, Inc. | 1991-10-17 |
| MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S004) | Davis & Geck, Inc. | 1991-03-29 |
| NOVAFIL(TM) (P840041/S003) | Davis & Geck, Inc. | 1990-07-06 |