DemeTECH DemeFORCE Nonabsorbable Surgical Suture
FDA 510(k) K190777 · Demetech Corporation
510(k) numberK190777
Submission
- Device name
- DemeTECH DemeFORCE Nonabsorbable Surgical Suture
- Applicant
- Demetech Corporation
Miami Lakes, FL, US - Received
- March 26, 2019
- Decision date
- July 31, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5000
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K261021 | EasyWhip FamilyGAT · Traditional | Winter Innovations, Inc. | 07/01/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | Teleflex Medical, LLC | 05/06/2026SE |
| K254275 | HyperSuture All Green Extension LineGAT · Traditional | Threadstone, LLC | 03/23/2026SE |
| K254188 | Meniscus VersaflexGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 02/19/2026SE |
| K253145 | Pre-Sutured TendonGAT · Special | Rti Surgical, Inc. | 10/22/2025SE |
| K253024 | ProZip Knotless ImplantGAT · Special | Riverpoint Medical | 10/16/2025SE |
| K252225 | PowerKnot High Strength SuturesGAT · Traditional | Medacta International S.A. | 09/12/2025SE |
| K252201 | HS FiberGAT · Special | Riverpoint Medical | 08/13/2025SE |
| K242201 | HyperSuture White/Green Extension LineGAT · Traditional | Threadstone, LLC | 03/27/2025SE |
More from Threadstone, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K201479 | DemeMASKFXX · Abbreviated | 07/24/2020SE |
| K191361 | DemeDIOX Barbed Absorbable Surgical SutureNEW · Traditional | 11/07/2019SE |
| 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 |
| K043330 | Polypropilene Surgical SuturesGAW · Traditional | 05/16/2005SE |
Questions and answers
When was DemeTECH DemeFORCE Nonabsorbable Surgical Suture cleared by the FDA?
DemeTECH DemeFORCE Nonabsorbable Surgical Suture (K190777) received a 510(k) decision of Substantially Equivalent on July 31, 2019, 127 days after the submission was received.
What is the product code of K190777?
The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.