510(k) K190937
- Device
- Echelon Endopath Staple Line Reinforcement
- Applicant
- Ethicon Endo-Surgery LLC
- 510(k) number
- K190937
- Product code
- OXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-14
- Date received
- 2019-04-10
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Absorbable, Staple Line Reinforcement
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Emily Nesbitt
- Address
- 475 Calle C Guaynabo PR US 00696 00696
FDA Registration Numbers#
- 3003910212
- 3027419979
- 3021194552
- 1213643
- 3014272734
- 3011137372
- 3010668881
- 3010041511
- 1527736
- 1319639
- 9613662
- 3002294946
- 3003898360
- 3018094310
- 3005075853
- 3006082230
- 1219930
- 3014479313
- 3005636544
- 3012481535
- 3009380063
Source Documents#
Other 510(k) Records For Product Code OXC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | Ethicon Endo-Surgery, LLC | 2026-01-09 |
| K231603 | Standard Staple-Line Reinforcement (SSLR23) | Standard Bariatrics, Inc. | 2023-10-06 |
| K221343 | ECHELON ENDOPATH Staple Line Reinforcement | Ethicon Endo-Surgery, LLC | 2022-09-16 |
| K221487 | NEOVEIL Staple Line Reinforcement | Gunze Limited | 2022-08-26 |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | W. L. Gore & Associates, Inc. | 2018-08-17 |
| K150551 | GORE SEAMGUARD Reinforcement | W. L. Gore & Associates, Inc. | 2015-03-30 |
| K130997 | NEOVEIL | Gunze Limited | 2013-11-15 |
| K131658 | GORE SEAMGUARD REINFORCEMENT | W. L. Gore & Associates, Inc. | 2013-09-06 |
Legacy Summary#
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FDA Review#
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