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)

Aspire Mechanical Aspirator G

K-Number: K200629 · 2020-05-29

ApplicantControl Medical Technology
Decision Date2020-05-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Aspire Mechanical Aspirator G is the device name listed in this FDA 510(k) record. The listed applicant is Control Medical Technology. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K200629. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aspire Mechanical Aspirator G?

Aspire Mechanical Aspirator G is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Control Medical Technology. The 510(k) number is K200629.

When did Aspire Mechanical Aspirator G receive FDA 510(k) clearance?

Aspire Mechanical Aspirator G received FDA 510(k) clearance on 2020-05-29, under 510(k) number K200629.

Who is the listed applicant for Aspire Mechanical Aspirator G?

The FDA 510(k) record lists Control Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aspire Mechanical Aspirator G?

The FDA product code for Aspire Mechanical Aspirator G is FMF.

Other records listing Control Medical Technology 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.

K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator

Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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.

↑