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FDA 510(k)

E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS

K-Number: K841720 · 1984-07-26

ApplicantE-Z-Em, Inc.
Decision Date1984-07-26
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS 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 1984-07-26 under 510(k) number K841720. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS?

E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS is a medical device that received FDA 510(k) clearance on 1984-07-26. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K841720.

When did E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS receive FDA 510(k) clearance?

E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS received FDA 510(k) clearance on 1984-07-26, under 510(k) number K841720.

Who is the listed applicant for E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS?

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 PERCUTANEOUS NEPHROSTOMY SETS?

The FDA product code for E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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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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