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)

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets

K-Number: K211911 · 2022-03-10

ApplicantColoplast Corp.
Decision Date2022-03-10
Product CodeLJE
DecisionUnknown

Device Summary

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K211911. The device is classified under product code LJE. FDA Decision: Unknown.

Frequently Asked Questions

What is the Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Coloplast Corp.. The 510(k) number is K211911.

When did Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets receive FDA 510(k) clearance?

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets received FDA 510(k) clearance on 2022-03-10, under 510(k) number K211911.

Who is the listed applicant for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

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

What is the FDA product code for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

The FDA product code for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets is LJE.

Other records listing Coloplast Corp. 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 P000006Device, impotence, mechanical/hydraulicPMA P020003Prosthesis, testicularK252140Heylo™ SystemK251116Luja CoudéK250270Luja SetK242049SureCath Set

View all 42 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)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 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.

↑