Data / Medical devices / United States / TURBETT SURGICAL, Inc
TURBETT SURGICAL, Inc: FDA-registered device maker in Macedon, NY, United States, 1 510(k) clearance
TURBETT SURGICAL, Inc is registered with the FDA (registration 3012421755) in Macedon, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 14, 2016. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012421755
- Address
- 1604 Wayneport Rd, Macedon, NY, United States, 14502
- Owner or operator
- Turbett Surgical, Inc (10051785)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 4, 2016
- Registered through
- 2026
- Brand names listed
- Turbett Surgical Container
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wrap, Sterilization | FRG | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 14, 2016 | K153025 | Turbett Surgical Container | FRG | Substantially Equivalent | Turbett Surgical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 5, 2022 | 91314 | Class II | Ongoing | Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. | accessdata.fda.gov |
| April 14, 2022 | 90578 | Class II | Terminated | Turbett Surgical Container, TS1500 | Devices were subject to unapproved rework processes. | accessdata.fda.gov |
| April 1, 2022 | 90132 | Class II | Ongoing | Turbett Surgical Container, TS1500 | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. | accessdata.fda.gov |
Compare with other makers
Updated January 30, 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.