Turbett Instrument Pod

FDA 510(k) K200240 · Turbett Surgical, Inc.

Substantially Equivalent

510(k) numberK200240

Submission

Device name
Turbett Instrument Pod
Applicant
Turbett Surgical, Inc.
Rochester, NY, US
Received
January 31, 2020
Decision date
April 30, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRG – Wrap, Sterilization
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6850
Specialty
General Hospital

Other 510(k)s with product code FRG

510(k)DeviceApplicantDecision
K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional O&M Halyard, Inc.07/02/2026SE
K252823Dukal Crepe Paper Sterilization WrapFRG · Traditional Dukal, LLC05/28/2026SE
K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional O&M Halyard, Inc.05/18/2026SE
K251347Sterilization Pouch/RollFRG · Traditional Sterivic Medical Co., Ltd.01/28/2026SE
K251177Self-Seal Sterilization Pouch and RollFRG · Traditional Guangdong Maidi Medical Co., Ltd.12/12/2025SE
K250306Chex-All Sterilization Pouches and TubesFRG · Abbreviated Propper Manufacturing Co., Inc.10/31/2025SE
K243179Sterilization Pouch and RollFRG · Traditional Yichang Xinxin Paper Products Co., Ltd.06/26/2025SE
K250321GCI Sterilization WrappersFRG · Traditional George Courey, Inc.06/06/2025SE
K243721Self Sealing Sterilization PouchesFRG · Traditional Wellmed Dental Medical Supply Co., Ltd.04/25/2025SE
K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional Turbett Surgical04/04/2025SE

More from Turbett Surgical

510(k)DeviceDecision
K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional 04/04/2025SE
K202593Turbett Instrument PodFRG · Traditional 05/19/2021SE
K153025Turbett Surgical ContainerFRG · Traditional 01/14/2016SE

Questions and answers

When was Turbett Instrument Pod cleared by the FDA?

Turbett Instrument Pod (K200240) received a 510(k) decision of Substantially Equivalent on April 30, 2020, 90 days after the submission was received.

What is the product code of K200240?

The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.