510(k) clearances

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)

Sutter Medizintechnik GmbH · General, Plastic Surgery

K233425Substantially EquivalentTraditionalGEI
Open FDA's page for this record
Third party flag
N
City
Emmendingen
Advisory committee description
General, Plastic Surgery
Address 1
Alfred-Walz-Str. 22
Statement or summary
Summary
Product code
GEI
Zip code
79312
Applicant
Sutter Medizintechnik GmbH
Decision date
2024-01-25
Decision code
SESE
Country code
DE
Device name
FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
Advisory committee
SU
Contact
Simone Peschl
K number
K233425
Date received
2023-10-11
Review advisory committee
SU
Postal code
79312
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
1051614, 3029972466, 3007593903, 3015497424, 3013247477, 3021192541, 1062741, 1720747, 8010273, 2518897, 3007728276, 1057358, 3028977843, 3003537036, 1000523114, 3002806603, 2029015, 3007535734, 3004601121, 3009555600, 9681129, 3016248634, 3011944170, 3006266622, 3007047889, 3008864603, 3014931612, 3006985163, 3005110411, 3011625895, 3004837686, 8043746, 3004111573, 3002808148, 3033589330, 3043226252, 3043532708, 3022626486, 3008911114, 3010400367 +832 more
FEI number
1051614, 3029972466, 3007593903, 3015497424, 3013247477, 3021192541, 1720747, 1000136191, 3007728276, 3001319476, 3028977843, 3003537036, 1000523114, 3002806603, 3004601121, 3007535734, 3009555600, 1000208624, 3006469671, 3016248634, 3008185830, 3011944170, 2523865, 3006266622, 3007047889, 3008864603, 3014931612, 3006985163, 3005110411, 3011625895, 3002806575, 3004837686, 3004111573, 3002808148, 3033589330, 3043226252, 1000116158, 3043532708, 1000640985, 3022626486 +832 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.