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TIPCAM 1S 3D System

by Karl Storz Endoscopy-America, Inc. 2 variants

510(k) K162410

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162410 Date2 Mar 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
EOB
FDA applicant
Karl Storz Endoscopy America, Inc.
Device Class
Class II
Regulation
21 CFR Part 874.4760
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 TIPCAM 1S 3D System is a nasopharyngoscope (flexible or rigid) used in ear, nose, and throat procedures. It is a class II medical device designed for visualization of the nasopharynx and related anatomical structures.

The device is supplied as a reusable system and has received FDA 510(k) clearance under K162410. It is intended for use in clinical settings by trained healthcare professionals and is not MRI conditional unless explicitly stated in the labeling.

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Questions

AI-generated answers, 23 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 TIPCAM 1S 3D System used for?

    The TIPCAM 1S 3D System is a nasopharyngoscope used in ear, nose, and throat procedures to visualize the nasopharynx and related anatomical structures, intended for clinical use by trained healthcare professionals.

  • Is the TIPCAM 1S 3D System reusable or single-use?

    The TIPCAM 1S 3D System is supplied as a reusable system, meaning it is designed for multiple uses after proper cleaning and reprocessing in accordance with the manufacturer's instructions.

  • What regulatory pathway was used for the TIPCAM 1S 3D System?

    The TIPCAM 1S 3D System received FDA 510(k) clearance under submission number K162410, indicating it was found substantially equivalent to a legally marketed predicate device.