Polyglytone 6211 Synthetic Absorbable Suture
FDA 510(k) K042141 · Teleflex Medical
510(k) numberK042141
Submission
- Device name
- Polyglytone 6211 Synthetic Absorbable Suture
- Applicant
- Teleflex Medical
Fall River, MA, US - Received
- August 9, 2004
- Decision date
- September 28, 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 |
|---|---|---|
| K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special | 07/09/2026SE |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | 05/06/2026SE |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | 07/03/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | 04/29/2025SE |
| K243553 | QuikClot Control+ Hemostatic DevicePOD · Traditional | 03/18/2025SE |
| K241784 | Arrow® Nitinol WireDQX · Traditional | 09/18/2024SE |
| K233713 | Pilling Tracheostomy TubesBTO · Traditional | 03/22/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | 01/12/2024SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | 08/30/2023SE |
| K231924 | EZ-IO Intraosseous Vascular Access SystemFMI · Special | 07/25/2023SE |
Questions and answers
When was Polyglytone 6211 Synthetic Absorbable Suture cleared by the FDA?
Polyglytone 6211 Synthetic Absorbable Suture (K042141) received a 510(k) decision of Substantially Equivalent on September 28, 2004, 50 days after the submission was received.
What is the product code of K042141?
The FDA product code is GAM – Suture, Absorbable, Synthetic, Polyglycolic Acid, a Class II (moderate risk) device regulated under 21 CFR 878.4493.