Nagashima Sft-i Laryngoscope Right-angl

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K821706 ↗

FDA Product Code

EQN

Device Class

Class II

Regulation

21 CFR Part 874.4760

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Nagashima Light Source Unit Sl-5

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  FDA 510(k) K821709 Active Cleared 25 Jun 1982

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  FDA 510(k) K822279 Active Cleared 25 Aug 1982

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  FDA 510(k) K822187 Active Cleared 24 Aug 1982

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  FDA 510(k) K822195 Active Cleared 25 Aug 1982

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  FDA 510(k) K822278 Active Cleared 27 Aug 1982

See all devices from Kelleher Corp. →

• What is the primary clinical use of the Nagashima Sft-i Laryngoscope?

  This device is specifically designed for use within the ear, nose, and throat medical specialty. Its primary function is to facilitate the visualization of the larynx and nasopharynx during clinical examinations.

• What is the regulatory status of this device?

  The Nagashima Sft-i Laryngoscope is regulated under FDA 510(k) clearance number K821706. It is classified under regulation number 874.4760 and was determined to be substantially equivalent to existing devices.

• Who is the manufacturer of the Nagashima Sft-i Laryngoscope?

  The device is manufactured by Kelleher Corp., located in McHenry, Illinois. They are the applicant responsible for the 510(k) submission associated with this product.