Atlas FDA

Ureteric Catheters

FDA 510(k) clearance K182122 · decided 2018-10-04

Clearance details

K-number
K182122
Device name
Ureteric Catheters
Applicant
Coloplast Corp.
Decision
Substantially Equivalent
Date received
2018-08-06
Decision date
2018-10-04
Days to decision
59 days
Clearance type
Traditional
Product code
EYB
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
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
RocaTub Ureteral Catheter (K192183)Promepal Sam2020-04-23
Dornier MINNOW Ureteral Catheter (K191187)Dornier Medtech America, Inc.2019-09-18
UPJ Occlusion Balloon Catheter (K183323)Cook Incorporated2019-08-05
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter (K182695)Cook Incorporated2019-06-17
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter (K180182)Cook Incorporated2018-09-14
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (K171043)Coloplast Corp.2017-12-21
OCCLUDER OCCLUSION BALLOON CATHETER (K133750)Boston Scientific Corporation2014-01-08
MEDLINE RED RUBBER URETHRAL CATHETER (K092250)Medline Industries, Inc.2010-01-21
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR (K083788)Endooptiks, Inc.2009-03-03
DUAL LUMEN CATHETER (K043581)Acmi Corporation2005-03-03
AMSURE RED RUBBER URETHRAL CATHETER (K030293)Amsino International, Inc.2004-02-04
FOSSA URETERAL OPEN LUMEN STENT (K033368)Fossa Medical, Inc.2003-11-26

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