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KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

by Karl Storz SE & CO. KG

510(k) K251731Ref 11001RD1

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251731↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048551000283TL Basic UDI-DI 04048551225608UDI-DIDate19 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK251731 Date5 Dec 2025ClearedStatusActive
United StatesGUDID listing GUDID Number04048551225608 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Flexible fibreoptic nasopharyngolaryngoscope
Device Name
Flexible endoscopes
Model / Reference
11001RD1
Primary DI / UDI-DI
04048551225608
Basic UDI-DI
4048551000283TL
510(k) Number
FDA Product Code
EOQ
EMDN Code
Z12021005 Nasal pharyngo/laryngoscopes
GMDN Term
Flexible fibreoptic nasopharyngolaryngoscope
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 874.4680
EU market of registration
Germany
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

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 Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) is a flexible endoscope designed for video-assisted intubation procedures. It combines a flexible shaft with an integrated camera system to provide real-time visualisation of the airway, aiding in precise and controlled intubation in clinical settings.

This device is supplied sterile and intended for single-use, ensuring patient safety and reducing cross-contamination risks. It is classified under the product code EOQ and is authorised under FDA 510K clearance with a Special review type. The endoscope is intended for use in otolaryngology and related procedures, adhering to regulatory standards for medical devices.

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Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No