510(k) clearances

ENDOFLATOR+; Smart Smoke Evacuation

Karl Storz SE & CO. KG · Obstetrics/Gynecology

K260209Substantially EquivalentTraditionalHIF
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
Statement or summary
Summary
Product code
HIF
Zip code
78532
Applicant
Karl Storz SE & CO. KG
Decision date
2026-08-19
Decision code
SESE
Country code
DE
Device name
ENDOFLATOR+; Smart Smoke Evacuation
Advisory committee
OB
Contact
Emily Rhiel
K number
K260209
Date received
2026-01-23
Review advisory committee
OB
Postal code
78532
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Insufflator, Laparoscopic
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.1730
Device class
2
Registration number
1450997, 1417592, 1526711, 3004491689, 3017565103, 3010220595, 3008595179, 3010041511, 3004111573, 3019269298, 3017590240, 3015612252, 1643817, 3010885402, 3007305485, 3008254127, 3005555621, 3012322232, 1836161, 3004605321, 1225984, 1064584, 3003604053, 3020746799, 1450662, 2936485, 2955842, 3012470322, 3041276591, 3015183635, 1317547, 3016248634, 3004784537, 3015974593, 1221051, 3002808148, 3010120217, 8030607, 3001003398, 3010202439 +107 more
FEI number
1450997, 3002806315, 1417592, 3002808273, 1526711, 3004491689, 3017565103, 3010220595, 3008595179, 3010041511, 3004111573, 3019269298, 3017590240, 3015612252, 1000125147, 1643817, 3010885402, 3007305485, 3008254127, 3005555621, 3012322232, 3006509795, 3004605321, 3001595430, 3003604053, 3020746799, 1450662, 2936485, 3012470322, 3041276591, 3015183635, 1000112877, 1317547, 3002808268, 3016248634, 3004784537, 3007475226, 3015974593, 1221051, 1000512168 +107 more
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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.