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FDA 510(k)

Turbett Surgical Container

K-Number: K153025 · 2016-01-14

ApplicantTurbett Surgical, LLC
Decision Date2016-01-14
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Turbett Surgical Container is the device name listed in this FDA 510(k) record. The listed applicant is Turbett Surgical, LLC. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K153025. 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 Surgical Container?

Turbett Surgical Container is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Turbett Surgical, LLC. The 510(k) number is K153025.

When did Turbett Surgical Container receive FDA 510(k) clearance?

Turbett Surgical Container received FDA 510(k) clearance on 2016-01-14, under 510(k) number K153025.

Who is the listed applicant for Turbett Surgical Container?

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

What is the FDA product code for Turbett Surgical Container?

The FDA product code for Turbett Surgical Container is FRG.

Other records listing Turbett Surgical, LLC 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 PodK200240Turbett Instrument Pod

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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