Biomer * Pledget Suture Buttress
FDA 510(k) K832138 · ETHICON, Inc.
510(k) numberK832138
Submission
- Device name
- Biomer * Pledget Suture Buttress
- Applicant
- ETHICON, Inc.
Walker, MI, US - Received
- July 1, 1983
- Decision date
- May 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGS – Retention Device, Suture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4930
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030031 | Soft Tissue Anchoring WashersKGS · Traditional | Accu-Speed, Incorporated | 01/28/2003SE |
| K020480 | RBMKGS · Special | Smith & Nephew, Inc. | 03/12/2002SE |
| K964935 | Suture LockKGS · Traditional | Smith & Nephew Endoscopy, Inc. | 02/25/1997SE |
| K941740 | Acufex Rotator Cuff Fixation ButtonKGS · Traditional | Acufex Microsurgical, Inc. | 06/30/1995SE |
| K930675 | Mitek Cone WasherKGS · Traditional | Mitek Surgical Products, Inc. | 11/09/1993SE |
| K904435 | Ventrofil Tension Relief Suture SetKGS · Traditional | Aesculap, Inc. | 08/29/1991SE |
| K911225 | Tray DoughKGS · Traditional | The Hygenic Corp. | 04/17/1991SE |
| K904136 | Suture Tension Adjustment ReelKGS · Traditional | Surgical Systems, Inc. | 10/02/1990SE |
| K902001 | Surgical Retention BarKGS · Traditional | Acufex Microsurgical, Inc. | 05/09/1990SE |
| K896310 | Acufex Fixation Button; Retention Bar, WedgeKGS · Traditional | Acufex Microsurgical, Inc. | 11/20/1989SE |
More from Acufex Microsurgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253394 | Coated VICRYL (Polyglactin 910) Plus Antibacterial SutureGAM · Traditional | 06/25/2026SE |
| K252047 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control DevicesNEW · Traditional | 05/18/2026SE |
| K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX…GAW · Traditional | 03/27/2026SE |
| K253852 | MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic…GAM · Traditional | 02/06/2026SE |
| K252743 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL…GAM · Traditional | 12/22/2025SE |
| K243897 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional | 11/12/2025SE |
| K221744 | STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceGAM · Traditional | 11/15/2022SE |
| K212380 | PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureNEW · Traditional | 02/22/2022SE |
| K213512 | DERMABOND PRINEO Skin Closure SystemOMD · Special | 12/07/2021SE |
| K201996 | Monocryl Plus Antibacterial SutureGAM · Traditional | 12/21/2020SE |
Questions and answers
When was Biomer * Pledget Suture Buttress cleared by the FDA?
Biomer * Pledget Suture Buttress (K832138) received a 510(k) decision of Substantially Equivalent on May 23, 1984, 327 days after the submission was received.
What is the product code of K832138?
The FDA product code is KGS – Retention Device, Suture, a Class I (low risk) device regulated under 21 CFR 878.4930.