Multitak Suture Snap System
FDA 510(k) K013177 · Bonutti Research, Inc.
510(k) numberK013177
Submission
- Device name
- Multitak Suture Snap System
- Applicant
- Bonutti Research, Inc.
Effingham, IL, US - Received
- September 24, 2001
- Decision date
- December 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4493
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional | ETHICON, Inc. | 06/25/2026SE |
| K253530 | Trexon Monofilament Synthetic Absorbable SutureGAM · Traditional | Medtronic | 05/28/2026SE |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional | ETHICON, Inc. | 02/06/2026SE |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional | ETHICON, Inc. | 12/22/2025SE |
| K253620 | TroClose 1200GAM · Special | Gordian Surgical, Ltd. | 12/16/2025SE |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90…GAM · Special | Internacional Farmacéutica S.A DE C.V | 10/03/2025SE |
| K233265 | Monotime and Optime RGAM · Abbreviated | Peters Surgical | 10/11/2024SE |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)GAM · Abbreviated | Peters Surgical | 07/12/2024SE |
| K221527 | StitchKitGAM · Traditional | Origami Surgical Inc . | 02/14/2023SE |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional | ETHICON, Inc. | 11/15/2022SE |
More from ETHICON, Inc.
| 510(k) | Device | Decision |
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| K161628 | JAS Pulse(TM) Ultrasonic TherapyIMI · Abbreviated | 11/10/2016SE |
| K093078 | Unity Ultrasonic System with Plla AnchorsHWC · Special | 06/23/2010SE |
| K090175 | Unity Beta Plla SystemHWC · Traditional | 09/10/2009SE |
| K082906 | Unity Beta Anchor SystemHWC · Special | 10/30/2008SE |
| K062820 | Unity Alpha SystemHWC · Traditional | 03/15/2007SE |
| K060283 | Transet SystemHTY · Special | 02/22/2006SE |
| K052799 | Multitak 6.0 MM Absorbable Anchor SystemMAI · Traditional | 12/16/2005SE |
| K033717 | Transet Fracture Fixation SystemHTY · Traditional | 02/25/2004SE |
| K012465 | Multitak Splinter 3.0 MM Resorbable AnchorMAI · Traditional | 10/29/2001SE |
| K010479 | Multitak Conical Tip Bone Soft Tissue Suture AnchorHTY · Traditional | 05/08/2001SE |
Questions and answers
When was Multitak Suture Snap System cleared by the FDA?
Multitak Suture Snap System (K013177) received a 510(k) decision of Substantially Equivalent on December 19, 2001, 86 days after the submission was received.
What is the product code of K013177?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.