510(k) clearances

Sonopet iQ Ultrasonic Aspirator System (5500-050-000)

Stryker Instruments · Unknown

K243930Substantially EquivalentTraditionalLFL
Open FDA's page for this record
Third party flag
N
City
Portage
Advisory committee description
Unknown
Address 1
1941 Stryker Way
Statement or summary
Summary
Product code
LFL
Zip code
49002
Applicant
Stryker Instruments
Decision date
2025-03-24
Decision code
SESE
Country code
US
Device name
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
Contact
Louise Keane
K number
K243930
State
MI
Date received
2024-12-20
Review advisory committee
SU
Postal code
49002
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Instrument, Ultrasonic Surgical
Medical specialty description
Unknown
Device class
U
Registration number
3021194552, 9613895, 9610612, 3011823740, 3018094310, 3013247477, 3016555232, 3014479313, 3035387162, 1650907, 8010047, 3008837339, 3015612252, 2029015, 3007225330, 9610773, 3026606306, 3021599290, 1061124, 3011063460, 2648988, 3004111573, 3002808148, 3007997036, 2030598, 3017820152, 3022626486, 3014932737, 3014635169, 3013665681, 3010141593, 1717344, 2182291, 3011024991, 3024021261, 3015183635, 3011989923, 2648666, 3032391, 3010684280 +102 more
FEI number
3021194552, 3011823740, 3018094310, 3013247477, 3016555232, 3014479313, 1000160458, 3035387162, 3008837339, 3015612252, 3007225330, 3003094575, 3021599290, 3026606306, 3011063460, 3002808224, 3002808148, 3004111573, 1000132435, 3007997036, 3017820152, 3022626486, 3014932737, 3014635169, 3013665681, 3010141593, 1000138054, 2182291, 1717344, 1000115735, 3011024991, 3003076831, 3024021261, 3002299608, 3015183635, 3011989923, 3002821504, 2648666, 3010684280, 3011050570 +101 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.