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FDA 510(k)

E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE

K-Number: K842121 · 1984-10-01

ApplicantE-Z-Em, Inc.
Decision Date1984-10-01
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1984-10-01 under 510(k) number K842121. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE?

E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K842121.

When did E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE receive FDA 510(k) clearance?

E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE received FDA 510(k) clearance on 1984-10-01, under 510(k) number K842121.

Who is the listed applicant for E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE?

The FDA product code for E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE is LJE.

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Other records listing E-Z-Em, 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.

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Related Devices (Code: LJE)

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.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated

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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