510(k) clearances

ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)

Reshape Lifesciences · Gastroenterology, Urology

K241039Substantially EquivalentSpecialKNT
Open FDA's page for this record
Third party flag
N
City
Irvine
Advisory committee description
Gastroenterology, Urology
Address 1
18 Technology Dr., Suite 110
Statement or summary
Summary
Product code
KNT
Zip code
92618
Applicant
Reshape Lifesciences
Decision date
2024-05-16
Decision code
SESE
Country code
US
Device name
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)
Advisory committee
GU
Contact
Eva Chang
K number
K241039
State
CA
Date received
2024-04-16
Review advisory committee
GU
Postal code
92618
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Tubes, Gastrointestinal (And Accessories)
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5980
Device class
2
Registration number
1214422, 3025772870, 3030446844, 3000268902, 9616088, 3006538822, 3018094310, 3013298431, 1313046, 3008044552, 3004122598, 9617594, 1223925, 3006673317, 3014421917, 2029015, 3014663754, 3013234390, 1055236, 9611590, 1314417, 3007285848, 3031289255, 3013524793, 1221485, 3005609751, 2183673, 1526012, 3017081712, 3004111573, 3014656668, 3014637079, 3011137372, 3043226252, 3010757606, 3044994889, 1221765, 3006271008, 3006017180, 3006157842 +193 more
FEI number
1214422, 3025772870, 3030446844, 3000268902, 3018094310, 3006538822, 1313046, 3013298431, 3008044552, 3004122598, 3002806565, 1000160458, 3014421917, 1000283452, 3002808127, 3014663754, 3013234390, 1000120555, 1314417, 3007285848, 3031289255, 3013524793, 1221485, 3005609751, 2183673, 3932, 3003015552, 1526012, 3017081712, 3004111573, 3014656668, 3014637079, 3043226252, 3000206435, 3010757606, 3044994889, 1221765, 3001236905, 3006017180, 3006271008 +192 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.