FDA 510(k)

Blue Eye (TS-905)

K-Number: K220434 · 2022-08-12

Decision Date2022-08-12

Product CodePLL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Blue Eye (TS-905) is the device name listed in this FDA 510(k) record. The listed applicant is The Standard Co., Ltd.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K220434. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blue Eye (TS-905)?

Blue Eye (TS-905) is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is The Standard Co., Ltd.. The 510(k) number is K220434.

When did Blue Eye (TS-905) receive FDA 510(k) clearance?

Blue Eye (TS-905) received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220434.

Who is the listed applicant for Blue Eye (TS-905)?

The FDA 510(k) record lists The Standard Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Eye (TS-905)?

The FDA product code for Blue Eye (TS-905) is PLL.

Other records listing The Standard Co., Ltd. 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.

K241591Blue Eye

Related Devices (Code: PLL)

K241591Blue EyeThe Standard Co., Ltd.K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)Ovesco Endoscopy AG K200071Blue Beacon Submucosal Injectable SolutionMicro-Tech (Nanjing) Co., Ltd.K202376EverLift Submucosal Lifting AgentGi Supply, Inc.K191923EverLift Submucosal Lifting AgentGi Supply K191254EndoClotEndoclot Plus Co., Ltd.

Official Source

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