Demetech Nylon Nonabsorbable Suture
FDA 510(k) K023028 · Demetech Corp.
510(k) numberK023028
Submission
- Device name
- Demetech Nylon Nonabsorbable Suture
- Applicant
- Demetech Corp.
Miami, FL, US - Received
- September 11, 2002
- Decision date
- June 18, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAR – Suture, Nonabsorbable, Synthetic, Polyamide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5020
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261484 | Tissue Approximation SystemGAR · Special | Tas Medical, Inc. | 06/03/2026SE |
| K220980 | Tissue Approximation System (TAS)GAR · Traditional | Tas Medical, Inc. | 07/05/2023SE |
| K212888 | Golnit Nylon Monofilament SutureGAR · Abbreviated | Antarma, LLC Dba Golnit Sutures | 03/31/2022SE |
| K212603 | Non Absorbable Surgical Nylon SutureGAR · Traditional | Shandong Haidike Medical Product Co., Ltd. | 12/22/2021SE |
| K192420 | Crownjun Nylon SutureGAR · Traditional | Kono Seisakusho Co., Ltd. | 05/29/2020SE |
| K161633 | Rexlon, RexsilGAR · Traditional | Sm Eng Co., Ltd. | 03/02/2017SE |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureGAR · Traditional | Aesculap, Inc. | 02/17/2016SE |
| K152795 | RiverLon (Nylon) SutureGAR · Special | Riverpoint Medical | 10/28/2015SE |
| K123034 | Vital Sutures Suturex Cirugia Peruana SutumedGAR · Traditional | Unilene Sac | 05/28/2013SE |
| K081366 | Kumar T-Anchors Hernia SetGAR · Traditional | Nashville Surgical Instruments | 07/15/2008SE |
More from Nashville Surgical Instruments
| 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 Demetech Nylon Nonabsorbable Suture cleared by the FDA?
Demetech Nylon Nonabsorbable Suture (K023028) received a 510(k) decision of Substantially Equivalent on June 18, 2003, 280 days after the submission was received.
What is the product code of K023028?
The FDA product code is GAR – Suture, Nonabsorbable, Synthetic, Polyamide, a Class II (moderate risk) device regulated under 21 CFR 878.5020.