Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZOOM Aspiration Pump

K-Number: K190105 · 2019-02-21

ApplicantTaiwan Biomaterial Co., Ltd.
Decision Date2019-02-21
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZOOM Aspiration Pump is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Biomaterial Co., Ltd.. It received FDA 510(k) clearance on 2019-02-21 under 510(k) number K190105. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOOM Aspiration Pump?

ZOOM Aspiration Pump is a medical device that received FDA 510(k) clearance on 2019-02-21. The listed applicant is Taiwan Biomaterial Co., Ltd.. The 510(k) number is K190105.

When did ZOOM Aspiration Pump receive FDA 510(k) clearance?

ZOOM Aspiration Pump received FDA 510(k) clearance on 2019-02-21, under 510(k) number K190105.

Who is the listed applicant for ZOOM Aspiration Pump?

The FDA 510(k) record lists Taiwan Biomaterial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOOM Aspiration Pump?

The FDA product code for ZOOM Aspiration Pump is JCX.

Other records listing Taiwan Biomaterial Co., Ltd. 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.

K180115TWBM Pump

Related Devices (Code: JCX)

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.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

Official Source

View on FDA Database →

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

↑