Schuring Ossicle Cup & Columella Prosth.

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K802431 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

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 Schuring Ossicle Cup & Columella Prosthesis used for?

  This prosthesis is designed for partial ossicular replacement in middle ear reconstruction, specifically for conditions like laterally healed tympanic membrane, absent stapes capitulum, remaining footplate crura, low-lying stapes, or retracted malleus.

• How is the Schuring Ossicle Cup & Columella Prosthesis supplied?

  The device is supplied as a sterile, single-use implant intended for surgical use in otolaryngology procedures. It comes ready for immediate surgical application without the need for additional sterilization.

• What is the regulatory classification of this device?

  The Schuring Ossicle Cup & Columella Prosthesis is classified as a Class II medical device under FDA regulation number 874.3450 and was cleared via the traditional 510(k) pathway (K802431) on November 12, 1980.

• What are the key features of the ossicle columella component?

  The ossicle columella component features a synthetic footplate that rests on the remaining footplate to provide stability and safety during middle ear reconstruction procedures.