Cypris eXact Suturing System
FDA 510(k) K233355 · Cypris Medical
510(k) numberK233355
Submission
- Device name
- Cypris eXact Suturing System
- Applicant
- Cypris Medical
Chicago, IL, US - Received
- September 29, 2023
- Decision date
- January 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K173644 | Gazelle Polypropylene Suture and Delivery DeviceGAW · Abbreviated | Dura Tap, LLC | 02/15/2018SE |
More from Dura Tap, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K240185 | Cypris eXact Suture Placement DeviceGEJ · Traditional | 05/03/2024SE |
Questions and answers
When was Cypris eXact Suturing System cleared by the FDA?
Cypris eXact Suturing System (K233355) received a 510(k) decision of Substantially Equivalent on January 12, 2024, 105 days after the submission was received.
What is the product code of K233355?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.