Quill Quadrahelix Tissue-Closure Device
FDA 510(k) K113800 · Angiotech
510(k) numberK113800
Submission
- Device name
- Quill Quadrahelix Tissue-Closure Device
- Applicant
- Angiotech
Reading, PA, US - Received
- December 23, 2011
- Decision date
- January 20, 2012
- 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 |
|---|---|---|
| K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignGAW · Special | 09/10/2015SE |
| K120827 | Quill Pdo Knotless Tissue-Closure Device (Polydixanone)NEW · Traditional | 07/13/2012SE |
| K113744 | Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)NEW · Traditional | 02/01/2012SE |
| K073672 | Skater Biliary CatheterFGE · Special | 01/24/2008SE |
| K070610 | Skater Biliary CatheterFGE · Traditional | 06/21/2007SE |
Questions and answers
When was Quill Quadrahelix Tissue-Closure Device cleared by the FDA?
Quill Quadrahelix Tissue-Closure Device (K113800) received a 510(k) decision of Substantially Equivalent on January 20, 2012, 28 days after the submission was received.
What is the product code of K113800?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.