Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop
FDA 510(k) K041806 · Depuy Mitek, A Johnson & Johnson Company
510(k) numberK041806
Submission
- Device name
- Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop
- Applicant
- Depuy Mitek, A Johnson & Johnson Company
Norwood, MA, US - Received
- July 6, 2004
- Decision date
- August 3, 2004
- 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 |
|---|---|---|
| K143660 | Milagro / Milagro Advance Interference ScrewMAI · Traditional | 05/21/2015SE |
| K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…MBI · Special | 10/24/2014SE |
| K140896 | Vapr Arctic Suction ElectrodeGEI · Traditional | 08/05/2014SE |
| K141259 | Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon PEEK…MAI · Special | 06/10/2014SE |
| K133794 | 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…MAI · Traditional | 02/04/2014SE |
| K132241 | Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…MAI · Traditional | 11/05/2013SE |
| K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMMBI · Traditional | 08/01/2013SE |
| K131974 | Healix Advance Knotless BR Anchor (6.5MM)MAI · Special | 07/25/2013SE |
| K131191 | 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur PLUS/4MM Barrel Tornado Bur Plus…HRX · Traditional | 07/22/2013SE |
| K130912 | Omnicut Resection BladeHRX · Traditional | 06/14/2013SE |
Questions and answers
When was Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop cleared by the FDA?
Passing Needle with Ethibond, Panacryl or Orthocord Suture; and Passing Needle with Ethibond Loop (K041806) received a 510(k) decision of Substantially Equivalent on August 3, 2004, 28 days after the submission was received.
What is the product code of K041806?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.