510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Gimbo Medical Technology Shenzhen Co., Ltd.

Shenzhen Guangdong, CN

GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Gimbo Medical Technology Shenzhen Co., Ltd. between 2024 and 2026. The busiest year on record is 2024, with 5. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Gimbo Medical Technology Shenzhen Co., Ltd., by decision year
YearClearances
20245
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval NeedleMQESubstantially Equivalent
K242043Sperm Freezing MediumMQLSubstantially Equivalent
K242968Giftlife® Single-Step Medium PlusMQLSubstantially Equivalent
K240002G-Vitri™ Vitrification StrawMQKSubstantially Equivalent
K240149Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step MediumMQLSubstantially Equivalent
K234023Oocyte Flushing & Retrieval Medium; Gamete BufferMQLSubstantially Equivalent
K232942G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing MediaMQLSubstantially Equivalent

Registered establishments

FDA registered establishments for Gimbo Medical Technology Shenzhen Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30306811103030681110GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD.601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Provinc, Shenzhen Guangdong 518107 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain