AROA Biosurgery Inc.
Airport Oaks Auckland, NZ
AROA BIOSURGERY INC. appears in FDA device records in Airport Oaks Auckland, NZ. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 24 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for AROA Biosurgery Inc. between 2017 and 2026. The busiest year on record is 2017, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260669 | Endoform Dermal Template | KGN | Substantially Equivalent | |
| K250598 | Endoform Reconstructive Template - PLGA | FTM | Substantially Equivalent | |
| K231305 | Endoform Dental Membrane | NPL | Substantially Equivalent | |
| K223373 | Enivo™ | BTA | Substantially Equivalent | |
| K200502 | Myriad Particles | KGN | Substantially Equivalent | |
| K200413 | Symphony | KGN | Substantially Equivalent | |
| K183398 | Endoform Restella | FTM | Substantially Equivalent | |
| K181935 | Endoform Reconstructive Template - Non Absorbable | FTL | Substantially Equivalent | |
| K172318 | Endoform Silver Dermal Template | FRO | Substantially Equivalent | |
| K171231 | Endoform Topical Matrix | KGN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015908545 | 3015908545 | AROA BIOSURGERY INC. | 9155 Brown Deer Road, San Diego, CA 92121 US | 2026 | No device listings on this registration |
| 3007321028 | 3007321028 | Aroa Biosurgery Ltd | 2 Kingsford Smith Place, Airport Oaks Auckland 2022 NZ | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0379-2019 | Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment. | Potential for pouch seal failure | Class II | Terminated | |
| Z-0378-2019 | Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment. | Potential for pouch seal failure | Class II | Terminated | |
| Z-0377-2019 | Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment. | Potential for pouch seal failure | Class II | Terminated | |
| Z-0435-2019 | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0434-2019 | OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0433-2019 | OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0432-2019 | OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0431-2019 | OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0430-2019 | OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0429-2019 | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0428-2019 | OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0427-2019 | OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0426-2019 | OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0425-2019 | OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0424-2019 | OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0423-2019 | OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0422-2019 | OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0421-2019 | OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0420-2019 | OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0419-2019 | OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0418-2019 | OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0417-2019 | OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0416-2019 | OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated | |
| Z-0415-2019 | OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain