Standard Bariatrics
Cincinnati, OH, US
Standard Bariatrics appears in FDA device records in Cincinnati, OH. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Standard Bariatrics between 2016 and 2023. The busiest year on record is 2021, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231603 | Standard Staple-Line Reinforcement (SSLR23) | OXC | Substantially Equivalent | |
| K222085 | Standard Tapered Bougie, 38 Fr. | KNT | Substantially Equivalent | |
| K212728 | Standard Bougie, 38 Fr. and Hand Pump | KNT | Substantially Equivalent | |
| K210437 | Standard Bougie, 38 Fr. | KNT | Substantially Equivalent | |
| K210278 | Titan SGS | GDW | Substantially Equivalent | |
| K200517 | Standard Trocar | GCJ | Substantially Equivalent | |
| K191885 | Standard Bougie | KNT | Substantially Equivalent | |
| K190788 | Disposable Standard Clamp | GCJ | Substantially Equivalent | |
| K181608 | Disposable Standard Clamp | GCJ | Substantially Equivalent | |
| K170379 | Disposable Standard Clamp | GCJ | Substantially Equivalent | |
| K161720 | Standard Clamp | GCJ | Substantially Equivalent | |
| K153358 | Standard Clamp | GDJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain