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FDA 510(k)

ECHO-COAT ULTRASOUND NEEDLES

K-Number: K983647 · 1999-01-20

ApplicantSts Biopolymers
Decision Date1999-01-20
Product CodeMJG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECHO-COAT ULTRASOUND NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Sts Biopolymers. It received FDA 510(k) clearance on 1999-01-20 under 510(k) number K983647. The device is classified under product code MJG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO-COAT ULTRASOUND NEEDLES?

ECHO-COAT ULTRASOUND NEEDLES is a medical device that received FDA 510(k) clearance on 1999-01-20. The listed applicant is Sts Biopolymers. The 510(k) number is K983647.

When did ECHO-COAT ULTRASOUND NEEDLES receive FDA 510(k) clearance?

ECHO-COAT ULTRASOUND NEEDLES received FDA 510(k) clearance on 1999-01-20, under 510(k) number K983647.

Who is the listed applicant for ECHO-COAT ULTRASOUND NEEDLES?

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

What is the FDA product code for ECHO-COAT ULTRASOUND NEEDLES?

The FDA product code for ECHO-COAT ULTRASOUND NEEDLES is MJG.

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Related Devices (Code: MJG)

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.

K080674PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEMPAJUNK GmbH MedizintechnologieK070836EXICLIP EXCS-MClevex, Inc.K955683RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAYContour Fabricators of Florida, Inc.K933324SKIN BIOPSY DEVICENhr, Inc.K925870SPACERBip USA, Inc.K922919DYNACYT BIOPSY ASPIRATION DEVICEBuckman Co., Inc.

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.

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