510(k) K162461
- Device
- Endoform Plastics And Reconstructive Matrix
- Applicant
- AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED)
- 510(k) number
- K162461
- Product code
- FTM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-20
- Date received
- 2016-09-02
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical
- 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
- Yasmin Rai
- Address
- 2 Kingsford Smith Pl., Airport Oaks Auckland NZ 2022 2022
FDA Registration Numbers#
- 1111225
- 3027448274
- 2024024
- 3009882464
- 2244478
- 3003936139
- 3007321028
- 1220948
- 3005636544
- 8010177
- 3010600625
- 3003300673
- 3005920706
- 3010400367
- 3012547639
- 1221816
- 3027383505
- 1047843
- 3018094310
- 9680579
- 1048735
- 1018233
- 2530154
- 3010894343
- 3008868758
- 2132242
- 2245304
- 1835959
- 3013307971
- 3015543569
- 1018470
- 3016003911
- 8043792
- 1818910
- 3004170064
- 1220477
- 1121308
- 3008812560
- 3009493875
- 9617465
- 3016823837
- 2124215
- 3036710971
- 1550222
- 3009417901
- 3002924436
- 3009039068
- 2023811
- 1820334
- 1526534
- 3002719998
- 3009504230
- 3013820501
- 3002807561
- 3003418325
- 3010513348
- 2246552
- 2030598
- 3000931034
- 3016429246
- 9614442
- 3015531529
- 3005619880
- 2183620
- 1000393132
- 3014461810
- 3012358417
- 3004464325
- 3013666218
- 1647098
- 2183744
- 3010178296
- 3012669262
- 3012448339
- 3015413883
- 1450662
- 3000215346
- 9615742
- 1213643
- 1649390
Source Documents#
Other 510(k) Records For Product Code FTM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250598 | Endoform Reconstructive Template - PLGA | Aroa Biosurgery , Ltd. | 2025-06-03 |
| K243595 | OviTex PRS (Long-Term Resorbable) | TELA Bio, Inc. | 2024-12-19 |
| K233991 | CanGaroo RM Antibacterial Envelope | Elutia, Inc. | 2024-06-14 |
| K241126 | OviTex PRS | TELA Bio, Inc. | 2024-05-22 |
| K223052 | Peri-Guard and Supple Peri-Guard | Synovis Life Technologies, Inc. | 2023-04-07 |
| K214070 | OviTex PRS (Long Term Resorbable) | Tela Bio | 2023-03-21 |
| K213163 | VersaWrap | Alafair Biosciences, Inc. | 2021-10-29 |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021-10-27 |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | Geistlich Pharma AG | 2021-07-14 |
| K203600 | VersaWrap | Alafair Biosciences, Inc. | 2021-03-09 |
| K192452 | Lyograft | B. Bruan Surgical, SA | 2020-09-03 |
| K201000 | Biodesign Staple Line Reinforcement | Cook Biotech Incorporated | 2020-07-13 |
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) | Aziyo Biologics, Inc. | 2020-06-15 |
| K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2020-03-06 |
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | Synovis Life Technologies, Inc. (Baxter International Inc.) | 2019-12-17 |
Legacy Summary#
summary
FDA Review#
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