Gazelle PTFE and Suture Delivery Device
FDA 510(k) K173335 · Dura Tap, LLC
510(k) numberK173335
Submission
- Device name
- Gazelle PTFE and Suture Delivery Device
- Applicant
- Dura Tap, LLC
Wayne, PA, US - Received
- October 23, 2017
- Decision date
- February 8, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NBY – Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5035
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NBY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231277 | TissueStatNBY · Traditional | Durastat, LLC | 11/09/2023SE |
| K192088 | GOLNIT Non-aborbable PTFE Surgical SutureNBY · Special | Antarma, LLC Dba Golnit Sutures | 09/04/2019SE |
| K180992 | BiotexNBY · Abbreviated | Purgo Biologics, Inc. | 07/16/2019SE |
| K191317 | StitchKitNBY · Traditional | Origami Surgical | 07/12/2019SE |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical SutureNBY · Traditional | Demetech Corporation | 10/11/2018SE |
| K180630 | PTFE Surgical SutureNBY · Special | Omnia Spa | 04/06/2018SE |
| K173922 | C-PTFETM Surgical SutureNBY · Traditional | Cp Medical, Inc. | 03/26/2018SE |
| K170842 | Wego-PtfeNBY · Traditional | Foosin Medical Supplies Inc., Ltd. | 07/31/2017SE |
| K163049 | GOLNIT Non-Absorbable PTFE Surgical SutureNBY · Traditional | Antarma Dba Golnit Sutures | 06/21/2017SE |
| K163639 | LS-5 ePTFE SutureNBY · Traditional | Lsi Solutions | 06/02/2017SE |
More from Lsi Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K173644 | Gazelle Polypropylene Suture and Delivery DeviceGAW · Abbreviated | 02/15/2018SE |
Questions and answers
When was Gazelle PTFE and Suture Delivery Device cleared by the FDA?
Gazelle PTFE and Suture Delivery Device (K173335) received a 510(k) decision of Substantially Equivalent on February 8, 2018, 108 days after the submission was received.
What is the product code of K173335?
The FDA product code is NBY – Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5035.