Spoon-Bobbin Drain Tube W/ Wire, Otology

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K760438 ↗

FDA Product Code

ETD

Device Class

Class II

Regulation

21 CFR Part 874.3880

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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See all devices from Richard'S Medical Equip., Inc. →

• What is the Spoon-Bobbin Drain Tube W/ Wire used for?

  The Spoon-Bobbin Drain Tube W/ Wire is a tympanostomy tube designed for otology procedures. It is specifically used to drain fluid from the middle ear and maintain proper ventilation in the ear.

• How is the Spoon-Bobbin Drain Tube supplied?

  The device is supplied by Richard's Medical Equip., Inc. It is classified as a Class II medical device under product code ETD and is designed for single-use in otology procedures.

• What is the regulatory status of this device?

  The Spoon-Bobbin Drain Tube W/ Wire received FDA 510(k) clearance with number K760438 on September 21, 1976. It is regulated under 874.3880 and is classified as a Class II medical device.

• Is this device reusable or single-use?

  The device is designed for single-use in otology procedures. It should not be reused as it is intended to be discarded after a single application to ensure patient safety and device integrity.