510(k) clearances

UNIDRIVE Select System

Karl Storz SE & CO. KG · Obstetrics/Gynecology

K261102Substantially EquivalentTraditionalHIH
Open FDA's page for this record
Third party flag
N
City
Tuttlingen
Advisory committee description
Obstetrics/Gynecology
Address 1
Dr.-Karl-Storz-Straße 34
Address 2
Baden-Wurttemberg
Statement or summary
Summary
Product code
HIH
Zip code
78532
Applicant
Karl Storz SE & CO. KG
Decision date
2026-09-18
Decision code
SESE
Country code
DE
Device name
UNIDRIVE Select System
Advisory committee
OB
Contact
McElroy Alita
K number
K261102
Date received
2026-04-03
Review advisory committee
OB
Postal code
78532
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Hysteroscope (And Accessories)
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.1690
Device class
2
Registration number
9617070, 9681753, 8043903, 3021610866, 3035781529, 3013247477, 3008693678, 3021632375, 3011986317, 3016667340, 3021246306, 3006787036, 3004111573, 9680515, 3014644276, 1418479, 8010877, 3030733800, 2085947, 1643817, 3012322232, 2936485, 3003724334, 3004361445, 1650907, 3011459664, 3015139943, 9610773, 3043226252, 3007829657, 3004784537, 3011011193, 3002808148, 9610595, 3009420598, 8010510, 3014407293, 3010202439, 3013944123, 3023365313 +96 more
FEI number
3021610866, 3035781529, 3002808273, 3013247477, 3008693678, 3021632375, 3011986317, 3016667340, 3000215205, 3021246306, 3006787036, 3004111573, 1418479, 3002808445, 3003565456, 1000136543, 3002807134, 3030733800, 3003276727, 1643817, 3012322232, 3001595430, 2936485, 3003724334, 3004361445, 3011459664, 3000219468, 3006149253, 3001236277, 3015139943, 3043226252, 3003186357, 3002808268, 3007829657, 3004784537, 3007475226, 3011011193, 3002808148, 3009420598, 1000132435 +96 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.