510(k) clearances

KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)

Karl Storz SE & CO. KG · Gastroenterology, Urology

K244001Substantially EquivalentTraditionalFBO
Open FDA's page for this record
Third party flag
N
City
Tuttlingen
Advisory committee description
Gastroenterology, Urology
Address 1
Dr.-Karl-Storz-Straße 34
Statement or summary
Summary
Product code
FBO
Zip code
78532
Applicant
Karl Storz SE & CO. KG
Decision date
2025-05-02
Decision code
SESE
Country code
DE
Device name
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
Advisory committee
GU
Contact
Thomas Ostrowski
K number
K244001
Date received
2024-12-26
Review advisory committee
GU
Postal code
78532
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Cystourethroscope
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
3014279513, 3007055279, 3012322232, 1319639, 9611102, 9614434, 3014342096, 9610595, 1221826, 8010047, 3010707607, 2020550, 1418479, 3006546082, 1519132, 3011050570, 3013247477, 3001614464, 3010202439, 3005465238, 3004644065, 9610617
FEI number
3014279513, 3002808001, 3007055279, 3012322232, 3014342096, 1221826, 3007475226, 3010707607, 2020550, 1418479, 3006546082, 1519132, 3011050570, 1000138054, 3013247477, 3001614464, 3002808273, 3005465238, 3002964398, 3004644065, 3002807795, 3002808268
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.