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)

ConceptoMed Luer-Jack Slip 10ml

K-Number: K162057 · 2017-01-11

ApplicantConceptomed AS
Decision Date2017-01-11
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ConceptoMed Luer-Jack Slip 10ml is the device name listed in this FDA 510(k) record. The listed applicant is Conceptomed AS. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162057. 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 ConceptoMed Luer-Jack Slip 10ml?

ConceptoMed Luer-Jack Slip 10ml is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Conceptomed AS. The 510(k) number is K162057.

When did ConceptoMed Luer-Jack Slip 10ml receive FDA 510(k) clearance?

ConceptoMed Luer-Jack Slip 10ml received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162057.

Who is the listed applicant for ConceptoMed Luer-Jack Slip 10ml?

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

What is the FDA product code for ConceptoMed Luer-Jack Slip 10ml?

The FDA product code for ConceptoMed Luer-Jack Slip 10ml is FMF.

Other records listing Conceptomed AS 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.

K171805Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml

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.

↑