Cleared Traditional

Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)

K250011 · Turbett Surgical · General Hospital

Apr 2025

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K250011 is an FDA 510(k) clearance for the Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000), a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Turbett Surgical (Henrietta, US). The FDA issued a Cleared decision on April 4, 2025, 92 days after receiving the submission on January 2, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K250011 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2025
Decision Date	April 04, 2025
Days to Decision	92 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF