Company ยท US
Standard Bariatrics
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2023. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 6, 2023 | K231603 | Standard Staple-Line Reinforcement (SSLR23) Standard Bariatrics, Inc. | OXC |
| Oct 31, 2022 | K222085 | Standard Tapered Bougie, 38 Fr. Standard Bariatrics, Inc. | KNT |
| Sep 23, 2021 | K212728 | Standard Bougie, 38 Fr. and Hand Pump Standard Bariatrics | KNT |
| Jun 29, 2021 | K210437 | Standard Bougie, 38 Fr. Standard Bariatrics | KNT |
| Apr 28, 2021 | K210278 | Titan SGS Standard Bariatrics | GDW |
| Apr 9, 2020 | K200517 | Standard Trocar Standard Bariatrics | GCJ |
| Apr 8, 2020 | K191885 | Standard Bougie Standard Bariatrics | KNT |
| Apr 18, 2019 | K190788 | Disposable Standard Clamp Standard Bariatrics | GCJ |
| Sep 27, 2018 | K181608 | Disposable Standard Clamp Standard Bariatrics | GCJ |
| Jul 19, 2017 | K170379 | Disposable Standard Clamp Standard Bariatrics | GCJ |
| Oct 24, 2016 | K161720 | Standard Clamp Standard Bariatrics | GCJ |
| May 2, 2016 | K153358 | Standard Clamp Standard Bariatrics | GDJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||