510(k) K251955
- Device
- Onflex Mesh
- Applicant
- Davol Inc., Subsidiary of C. R. Bard, Inc.
- 510(k) number
- K251955
- Product code
- FTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-24
- Date received
- 2025-06-25
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Polymeric
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Mohammed Ahmed
- Address
- 100 Crossings Blvd. Warwick RI US 02886 02886
FDA Registration Numbers
- 1614993
- 3024021261
- 2024311
- 1423537
- 1061771
- 2029275
- 2024024
- 2528981
- 3002807523
- 3003936139
- 3031978586
- 3027616027
- 3007321028
- 3005636544
- 3015194982
- 8010177
- 3009749957
- 3007663067
- 3006121828
- 3016248634
- 3017196117
- 1047843
- 2032112
- 9616088
- 3018094310
- 2011171
- 3022140316
- 3010331645
- 1048735
- 3020983460
- 1319639
- 1018233
- 2530154
- 1835959
- 2182208
- 1018470
- 2031966
- 3009756327
- 1064858
- 3013111980
- 9614846
- 3015860534
- 3013188547
- 3014479313
- 3010673515
- 3015231789
- 2219920
- 3008812560
- 8020712
- 8044102
- 3017102971
- 2435947
- 9617465
- 2124215
- 1422634
- 3009417901
- 3004111573
- 3039256597
- 3002294946
- 3003910212
- 3015453963
- 3009380063
- 3004661493
- 1221934
- 3009337401
- 1061124
- 1526534
- 1221051
- 3007109793
- 3010383847
- 1017294
- 3010291427
- 1220246
- 1226146
- 3002807315
- 3033302333
- 2132588
- 3016678045
- 3011582224
- 3002807561
Source Documents
Other 510(k) Records For Product Code FTL
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| K223218 | Parietene Macroporous Mesh | Sofradim Production | 2022-12-02 |
| K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2022-11-28 |
| K220540 | ProGrip Self-Gripping Polypropylene Mesh | Covidien | 2022-09-22 |