Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Standard Bariatrics with 12 510(k) clearances. The most recent is a 510(k) clearance dated Oct 6, 2023: Standard Staple-Line Reinforcement (SSLR23).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 6, 2023 | Standard Staple-Line Reinforcement (SSLR23)K231603 · OXC | 510(k) clearances |
| Oct 31, 2022 | Standard Tapered Bougie, 38 Fr.K222085 · KNT | 510(k) clearances |
| Sep 23, 2021 | Standard Bougie, 38 Fr. and Hand PumpK212728 · KNT | 510(k) clearances |
| Jun 29, 2021 | Standard Bougie, 38 Fr.K210437 · KNT | 510(k) clearances |
| Apr 28, 2021 | Titan SGSK210278 · GDW | 510(k) clearances |
| Apr 9, 2020 | Standard TrocarK200517 · GCJ | 510(k) clearances |
| Apr 8, 2020 | Standard BougieK191885 · KNT | 510(k) clearances |
| Apr 18, 2019 | Disposable Standard ClampK190788 · GCJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
