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FDA 510(k)

Turbett Instrument Pod

K-Number: K200240 · 2020-04-30

ApplicantTurbett Surgical, Inc.
Decision Date2020-04-30
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Turbett Instrument Pod is the device name listed in this FDA 510(k) record. The listed applicant is Turbett Surgical, Inc.. It received FDA 510(k) clearance on 2020-04-30 under 510(k) number K200240. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Turbett Instrument Pod?

Turbett Instrument Pod is a medical device that received FDA 510(k) clearance on 2020-04-30. The listed applicant is Turbett Surgical, Inc.. The 510(k) number is K200240.

When did Turbett Instrument Pod receive FDA 510(k) clearance?

Turbett Instrument Pod received FDA 510(k) clearance on 2020-04-30, under 510(k) number K200240.

Who is the listed applicant for Turbett Instrument Pod?

The FDA 510(k) record lists Turbett Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Turbett Instrument Pod?

The FDA product code for Turbett Instrument Pod is FRG.

Other records listing Turbett Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250011Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)K202593Turbett Instrument PodK153025Turbett Surgical Container

Related Devices (Code: FRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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