Data / Medical devices / United States / Tuttnauer Usa Co. Ltd.
Tuttnauer Usa Co. Ltd.: FDA-registered device maker in Hauppauge, NY, United States, 10 510(k) clearances
Tuttnauer Usa Co. Ltd. is registered with the FDA (registration 2435367) in Hauppauge, NY, United States. It lists 1 device type. The FDA files 10 510(k) clearances under its listings, the newest dated November 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2435367
- Address
- 345 Oser Avenue --, Hauppauge, NY, United States, 11788
- Owner or operator
- TUTTNAUER USA CO. LTD. (1450514)
- Roles
- Manufacturer
- First device listed
- December 12, 2007
- Registered through
- 2026
- Brand names listed
- 1730ME , 2340ME, 2540ME, 2340EKA, 2340M, 2540EEKEAEKA, 2540M, 3870 HSG, 3870 HSG WS, 3870EA, 3870EAP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer, Steam | FLE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2023 | K232658 | T-Top 10 & T-Top T-Top 11 | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| December 16, 2022 | K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| January 4, 2022 | K213080 | T-Edge 10, T-Edge 11 | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| July 8, 2019 | K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | FLE | Substantially Equivalent | Tuttnauer , Ltd. | accessdata.fda.gov |
| January 15, 2015 | K143311 | Pre-vacuum Tabletop Autoclave | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| December 8, 2011 | K111736 | TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| February 2, 2007 | K063711 | TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| October 29, 1997 | K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer U.S.A Co, Ltd. | accessdata.fda.gov |
| July 8, 1993 | K920478 | TUTTNAUER LSI (AUTOMATIC) | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
| January 11, 1984 | K833837 | AMERICAN GOLD SERIES AUTOCLAVE | FLE | Substantially Equivalent | Tuttnauer Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.