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Karl Storz Autofluorescence System

by Karl Storz Endoscopy-America, Inc.

PMA P020008510(k) K933216

Active United States

PMA, withdrawn 510(k)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), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP020008 Date12 Dec 2002ApprovedStatusWithdrawn
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK933216 Date9 Sep 1993ClearedStatusActive

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Generic Name
SYSTEM, IMAGING, FLUORESCENCE
PMA Number
510(k) Number
FDA Product Code
FFS
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Karl Storz Autofluorescence System is a fluorescence imaging system designed for use in white light and autofluorescence bronchoscopy. It assists clinicians in identifying and locating abnormal bronchial tissue to facilitate biopsy and histological evaluation.

This system is indicated for patients suspected of having bronchogenic carcinoma, those previously diagnosed with lung cancer at high risk for recurrence, or patients presenting with abnormal sputum cytology or imaging findings. It is intended for use as part of a standard diagnostic staging or work-up process.

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Questions

AI-generated answers, 18 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 primary purpose of the Karl Storz Autofluorescence System?

    The system is used during bronchoscopy to help clinicians identify and locate abnormal bronchial tissue that may require biopsy and further histological evaluation.

  • Which patients are candidates for this diagnostic procedure?

    It is indicated for patients suspected of having bronchogenic carcinoma, those with a history of lung cancer at high risk for recurrence, or individuals with abnormal findings in sputum cytology, chest X-rays, or CT scans.

  • Does this system support standard white light bronchoscopy?

    Yes, the system is specifically indicated for use in both white light and autofluorescence bronchoscopy to provide comprehensive visualization during the diagnostic process.