TURBETT SURGICAL, Inc
Henrietta, NY, US
TURBETT SURGICAL, Inc appears in FDA device records in Henrietta, NY. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for TURBETT SURGICAL, Inc between 2016 and 2025. The busiest year on record is 2016, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | FRG | Substantially Equivalent | |
| K202593 | Turbett Instrument Pod | FRG | Substantially Equivalent | |
| K200240 | Turbett Instrument Pod | FRG | Substantially Equivalent | |
| K153025 | Turbett Surgical Container | FRG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012421755 | 3012421755 | TURBETT SURGICAL, Inc | 1604 Wayneport Rd, Macedon, NY 14502 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1038-2023 | Turbett Surgical Container, TS1000: 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. | Class II | Open, Classified | |
| Z-1037-2023 | 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. | Class II | Open, Classified | |
| Z-1501-2022 | Turbett Surgical Container, TS1500 | Devices were subject to unapproved rework processes. | Class II | Terminated | |
| Z-1111-2022 | Turbett Surgical Container, TS1500 | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain