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FDA 510(k)

Telepack +

K-Number: K221174 · 2022-05-13

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2022-05-13
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Telepack + is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2022-05-13 under approval number K221174. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Telepack +?

Telepack + is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K221174.

When was Telepack + approved by the FDA?

Telepack + received FDA 510(k) clearance on 2022-05-13, under approval number K221174.

What company makes Telepack +?

Telepack + is manufactured by Karl Storz Endoscopy America, Inc..

What is the FDA product code for Telepack +?

The FDA product code for Telepack + is FET.

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Related Devices (Code: FET)

K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments Corporation

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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