OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners
FDA 510(k) K191287 · Davol Inc., Subsidiary of C.R. Bard
510(k) numberK191287
Submission
- Device name
- OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners
- Applicant
- Davol Inc., Subsidiary of C.R. Bard
Warwick, RI, US - Received
- May 13, 2019
- Decision date
- July 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GDW – Staple, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/11/2026SE |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional | Covidien (Part of Medtronic) | 04/10/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 10/28/2024SE |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special | Fengh Medical Co., Ltd. | 10/04/2024SE |
| K222487 | Anika Tissue Tack Fixation SystemGDW · Traditional | Anika Therapeutics, Inc. | 05/08/2023SE |
| K222210 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 04/21/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | Ethicon Endo-Surgery | 03/15/2023SE |
More from Ethicon Endo-Surgery
Questions and answers
When was OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners cleared by the FDA?
OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners (K191287) received a 510(k) decision of Substantially Equivalent on July 16, 2019, 64 days after the submission was received.
What is the product code of K191287?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.