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)

Lawson Retrograde Nephrostomy Wire Puncture Set

K-Number: K190903 · 2019-12-16

ApplicantCook Incorporated
Decision Date2019-12-16
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

Lawson Retrograde Nephrostomy Wire Puncture Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K190903. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lawson Retrograde Nephrostomy Wire Puncture Set?

Lawson Retrograde Nephrostomy Wire Puncture Set is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Cook Incorporated. The 510(k) number is K190903.

When did Lawson Retrograde Nephrostomy Wire Puncture Set receive FDA 510(k) clearance?

Lawson Retrograde Nephrostomy Wire Puncture Set received FDA 510(k) clearance on 2019-12-16, under 510(k) number K190903.

Who is the listed applicant for Lawson Retrograde Nephrostomy Wire Puncture Set?

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

What is the FDA product code for Lawson Retrograde Nephrostomy Wire Puncture Set?

The FDA product code for Lawson Retrograde Nephrostomy Wire Puncture Set is LJE.

Other records listing Cook Incorporated 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.

PMA P020018SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTK233177Nest VT Vitrification DeviceK222254Gunther Tulip Vena Cava Filter Retrieval SetK223098Bakri Essential Postpartum BalloonK210734Endovascular Dilator and SetsK203670Extra Large Check-Flo Introducer

View all 147 devices →

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 IncorporatedK183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent 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.

↑