Stitchkit
FDA 510(k) K123811 · Origami Surgical, LLC
510(k) numberK123811
Submission
- Device name
- Stitchkit
- Applicant
- Origami Surgical, LLC
Dover, MA, US - Received
- December 11, 2012
- Decision date
- September 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K173335 | Gazelle PTFE and Suture Delivery DeviceNBY · Abbreviated | Dura Tap, LLC | 02/08/2018SE |
| 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 |
More from Antarma Dba Golnit Sutures
| 510(k) | Device | Decision |
|---|---|---|
| K221527 | StitchKitGAM · Traditional | 02/14/2023SE |
| K211792 | StitchKitGAM · Special | 07/16/2021SE |
| K202950 | StitchKit COMBOGAM · Traditional | 02/23/2021SE |
| K191317 | StitchKitNBY · Traditional | 07/12/2019SE |
| K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOGAM · Traditional | 05/04/2018SE |
| K142639 | StitchKitGAW · Traditional | 12/16/2014SE |
Questions and answers
When was Stitchkit cleared by the FDA?
Stitchkit (K123811) received a 510(k) decision of Substantially Equivalent on September 5, 2013, 268 days after the submission was received.
What is the product code of K123811?
The FDA product code is NBY – Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5035.