510(k) K211911

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets by Coloplast Corp. — Product Code LJE

K211911 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets". The FDA issued a decision of Substantially Equivalent (kit) on March 10, 2022. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Coloplast Corp. has at least 10 other 510(k) clearances on record.