510(k) clearances

Oocyte Flushing & Retrieval Medium; Gamete Buffer

Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics/Gynecology

K234023Substantially EquivalentTraditionalMQL
Open FDA's page for this record
Third party flag
N
City
Shezhen
Advisory committee description
Obstetrics/Gynecology
Address 1
601, Bldg. C5, # 459 Qiaokai Rd., Fenghuang St.
Address 2
Guangming District
Statement or summary
Statement
Product code
MQL
Zip code
518107
Applicant
Gimbo Medical Technology Shenzhen Co., Ltd.
Decision date
2024-05-10
Decision code
SESE
Country code
CN
Device name
Oocyte Flushing & Retrieval Medium; Gamete Buffer
Advisory committee
OB
Contact
Leo Guo
K number
K234023
Date received
2023-12-20
Review advisory committee
OB
Postal code
518107
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Media, Reproductive
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.6180
Device class
2
Registration number
3030390242, 3007738736, 3036725842, 3017896194, 3003766921, 3016126174, 3018010054, 3012853704, 2022379, 1221433, 3014295858, 3025773437, 3014755376, 3008876063, 3007800906, 3004048494, 3015140190, 3004882774, 1222779, 3003274090, 3005580113, 3036495174, 3021166069, 3003995932, 9616005, 1216677, 3033813683, 3010413864, 3003272500, 2031824, 3030681110
FEI number
3030390242, 3007738736, 3036725842, 3017896194, 3003766921, 3016126174, 3018010054, 3012853704, 2022379, 1221433, 3014295858, 3004848623, 3025773437, 3014755376, 3008876063, 3007800906, 3004048494, 3015140190, 3004882774, 3002757762, 1000120774, 3005580113, 3003274090, 3036495174, 3021166069, 3003995932, 1216677, 3033813683, 3010413864, 3003272500, 3030681110
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.