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Carl Zeiss Inn Myringotomy Tube Line

by James L. Geraci & Associates, Inc.

510(k) K811698

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811698 Date31 Aug 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ETD
Device Class
Class II
Regulation
21 CFR Part 874.3880
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Carl Zeiss Inn Myringotomy Tube Line is a tympanostomy tube device used in ear, nose, and throat procedures. It is designed for insertion into the tympanic membrane to treat conditions such as chronic otitis media with effusion.

The device is supplied in various sizes and models as specified in the product line. It is a Class II medical device that received FDA 510(k) clearance in 1981. The device is not indicated for MRI use and should be stored according to manufacturer instructions.

Other devices from James L. Geraci & Associates, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Carl Zeiss Inn Myringotomy Tube Line used for?

    The Carl Zeiss Inn Myringotomy Tube Line is a tympanostomy tube device designed for insertion into the tympanic membrane to treat conditions such as chronic otitis media with effusion in ear, nose, and throat procedures.

  • How is the Carl Zeiss Inn Myringotomy Tube Line supplied?

    The device is supplied in various sizes and models as specified in the product line. It is a Class II medical device that received FDA 510(k) clearance in 1981.

  • Is the Carl Zeiss Inn Myringotomy Tube Line suitable for MRI use?

    No, the Carl Zeiss Inn Myringotomy Tube Line is not indicated for MRI use. It should be stored according to the manufacturer's instructions.

  • What is the regulatory status of the Carl Zeiss Inn Myringotomy Tube Line?

    The Carl Zeiss Inn Myringotomy Tube Line is a Class II medical device that received FDA 510(k) clearance in 1981 with the decision code SESE, indicating it is substantially equivalent to other devices on the market.