Prodek
FDA 510(k) K953609 · Sutures , Ltd.
510(k) numberK953609
Submission
- Device name
- Prodek
- Applicant
- Sutures , Ltd.
Ruabon, Wrexham, GB - Received
- August 2, 1995
- Decision date
- January 31, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional | ETHICON, Inc. | 03/27/2026SE |
| K233355 | Cypris eXact Suturing SystemGAW · Traditional | Cypris Medical | 01/12/2024SE |
| K230746 | Non absorbable Surgical Polypropylene SutureGAW · Traditional | Shandong Haidike Medical Products Co., Ltd. | 09/14/2023SE |
| K221280 | VessealGAW · Traditional | Lydus Medical , Ltd. | 12/09/2022SE |
| K211178 | DURAMESH Mesh SutureGAW · Traditional | Msi | 09/02/2022SE |
| K192953 | APTOS Threads Polypropylene Surgical SuturesGAW · Traditional | Aptos, LLC | 08/27/2020SE |
| K193530 | Deklene MAXXGAW · Special | Teleflex Medical | 03/19/2020SE |
| K191299 | Silhouette Featherlift / Silhouette LiftGAW · Special | Silhouette Lift, Inc. | 06/14/2019SE |
| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
| K180321 | Aesculap Optilene Nonabsorbable SutureGAW · Special | Aesculap, Inc. | 03/07/2018SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990432 | SurgisorbGAM · Traditional | 05/27/1999SN |
| K943627 | SurgisilkGAP · Traditional | 12/05/1994SN |
| K943223 | Surgidek BGAR · Traditional | 12/05/1994SN |
| K943222 | Surgidek SGAR · Traditional | 12/05/1994SN |
| K943221 | SurgibondGAT · Traditional | 12/05/1994SN |
| K943220 | SutuleneGAT · Traditional | 12/05/1994SN |
| K943218 | Chromic CatgutGAL · Traditional | 12/05/1994SN |
| K943217 | Plain CatgutGAL · Traditional | 12/05/1994SN |
| K943216 | SurgidekGAR · Traditional | 12/05/1994SN |
| K865038 | SurgisteelGAQ · Traditional | 06/30/1987SE |
Questions and answers
When was Prodek cleared by the FDA?
Prodek (K953609) received a 510(k) decision of Substantially Equivalent for Some Indications on January 31, 1996, 182 days after the submission was received.
What is the product code of K953609?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.