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FDA 510(k)

Renova RP Centesis Pump

K-Number: K221042 · 2023-04-19

ApplicantGi Supply, Inc.
Decision Date2023-04-19
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renova RP Centesis Pump is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply, Inc.. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K221042. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renova RP Centesis Pump?

Renova RP Centesis Pump is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Gi Supply, Inc.. The 510(k) number is K221042.

When did Renova RP Centesis Pump receive FDA 510(k) clearance?

Renova RP Centesis Pump received FDA 510(k) clearance on 2023-04-19, under 510(k) number K221042.

Who is the listed applicant for Renova RP Centesis Pump?

The FDA 510(k) record lists Gi Supply, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renova RP Centesis Pump?

The FDA product code for Renova RP Centesis Pump is BTA.

Other records listing Gi Supply, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202376EverLift Submucosal Lifting AgentK191923EverLift Submucosal Lifting Agent

Related Devices (Code: BTA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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