Polypropilene Surgical Sutures
FDA 510(k) K043330 · Demetech Corp.
510(k) numberK043330
Submission
- Device name
- Polypropilene Surgical Sutures
- Applicant
- Demetech Corp.
Appollo Beach, FL, US - Received
- December 2, 2004
- Decision date
- May 16, 2005
- 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 |
| 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 |
|---|---|---|
| K201479 | DemeMASKFXX · Abbreviated | 07/24/2020SE |
| K191361 | DemeDIOX Barbed Absorbable Surgical SutureNEW · Traditional | 11/07/2019SE |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical SutureGAT · Traditional | 07/31/2019SE |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical SutureNBY · Traditional | 10/11/2018SE |
| K181582 | DemeTECH DemeDIOX absorbable surgical sutureNEW · Special | 08/27/2018SE |
| K141007 | Demesteel (Stainless Steel) Non-Absorbable SutureGAQ · Traditional | 09/25/2014SE |
| K123940 | Demequicktm (Rapid Absorbable) Synthetic Surgical SutureGAM · Traditional | 05/30/2014SE |
| K130083 | Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureGAM · Traditional | 07/17/2013SE |
| K082097 | Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable SutureNEW · Traditional | 01/08/2010SE |
| K072930 | Demetech Absorbable Surgical Suture Plain & Chromic GutGAL · Traditional | 04/30/2008SE |
Questions and answers
When was Polypropilene Surgical Sutures cleared by the FDA?
Polypropilene Surgical Sutures (K043330) received a 510(k) decision of Substantially Equivalent on May 16, 2005, 165 days after the submission was received.
What is the product code of K043330?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.