Atlas FDA

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

FDA 510(k) clearance K211911 · decided 2022-03-10

Clearance details

K-number
K211911
Device name
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
Applicant
Coloplast Corp.
Decision
Unknown
Date received
2021-06-21
Decision date
2022-03-10
Days to decision
262 days
Clearance type
Traditional
Product code
LJE
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Plymouth, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Disposable Percutaneous Nephrostomy Dilatation Kit (K250448)Shenzhen Trious Medical Technology Co., Ltd.2025-07-03
Introducer Needle (K222705)Youcare Technology Co.,Ltd. (Wuhan)2023-05-22
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (K201165)Coloplast Corp.2020-12-17
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (K191498)Cook Incorporated2020-01-29
Lawson Retrograde Nephrostomy Wire Puncture Set (K190903)Cook Incorporated2019-12-16
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (K183051)Cook Incorporated2019-07-16
Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle (K183035)Cook Incorporated2019-05-17
Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (K181735)Cook Incorporated2019-03-27
Ultraxx Nephrostomy Balloon Catheter Set (K181713)Cook Incorporated2018-08-17
Ultraxx Nephrostomy Balloon Catheter (K171601)Cook Incorporated2018-02-23
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath (K172929)Boston Scientific Corporation2018-01-10
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe (K172527)Cook Incorporated2017-10-19

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Titan Inflatable Penile Prosthesis (P000006/S071)Coloplast Corp.2025-08-14
Titan Inflatable Penile Prosthesis (P000006/S070)Coloplast Corp.2025-05-28
Titan Inflatable Penile Prosthesis (IPP) (P000006/S069)Coloplast Corp.2024-10-02
Titan Inflatable Penile Prosthesis (IPP) (P000006/S068)Coloplast Corp.2024-07-09
Titan Inflatable Penile Prosthesis (IPP) (P000006/S067)Coloplast Corp.2024-02-05
Titan Inflatable Penile Prosthesis (IPP) (P000006/S064)Coloplast Corp.2023-03-03
Titan Inflatable Penile Prosthesis (IPP) (P000006/S066)Coloplast Corp.2023-02-15
Titan Inflatable Penile Prosthesis (IPP) (P000006/S065)Coloplast Corp.2023-01-12