Superstitch Vascular Suturing Device
FDA 510(k) K012865 · Sutura, Inc.
510(k) numberK012865
Submission
- Device name
- Superstitch Vascular Suturing Device
- Applicant
- Sutura, Inc.
Fountain Valley, CA, US - Received
- August 27, 2001
- Decision date
- September 25, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K062125 | Superstitch 5F, 12F, and ElGAW · Special | 10/19/2006SE |
| K053482 | Superstitch GW, Models 06-15-04-GW, 08-15-04-GWGAW · Special | 12/27/2005SE |
| K020940 | Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00XGAW · Special | 04/17/2002SE |
| K994087 | SuperstitchOCW · Traditional | 03/01/2000SE |
Questions and answers
When was Superstitch Vascular Suturing Device cleared by the FDA?
Superstitch Vascular Suturing Device (K012865) received a 510(k) decision of Substantially Equivalent on September 25, 2001, 29 days after the submission was received.
What is the product code of K012865?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.