510(k) Report

FDA applicant

Turbett Surgical, Inc.

Rochester, NY4 decisions2016–20254 recalls

FDA records 4 decisions for Turbett Surgical, Inc. (Rochester, NY) from 2016 to 2025: 4 510(k) clearances. All are in product code FRG (Wrap, Sterilization). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Turbett Surgical, LLC”, “Turbett Surgical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Turbett Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12020: 12021: 12025: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

4in 2022

2022: 4
2016high 4 (2022) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Turbett Surgical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Turbett Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FRGWrap, Sterilization4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 91 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 141 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200240Turbett Instrument PodTurbett Surgical, Inc. · 20201cites it
  • K153025Turbett Surgical ContainerTurbett Surgical, LLC · 20161cites it
  • K202593Turbett Instrument PodTurbett Surgical, Inc. · 20211cites it

What has FDA decided for it lately?

  • K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical…Turbett Surgical · 2025
  • K202593Turbett Instrument PodTurbett Surgical, Inc. · 2021
  • K200240Turbett Instrument PodTurbett Surgical, Inc. · 2020
  • K153025Turbett Surgical ContainerTurbett Surgical, LLC · 20164 recalls

All 2 as Turbett Surgical, Inc. →The one decision as Turbett Surgical, LLC →The one decision as Turbett Surgical →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K153025Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that…Dec 5, 2022Class II
  • K153025Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that…Dec 5, 2022Class II
  • K153025Turbett Surgical Container, TS1500Apr 14, 2022Class II
  • K153025Turbett Surgical Container, TS1500Apr 1, 2022Class II