Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
FDA 510(k) clearance K182695 · decided 2019-06-17
Clearance details
- K-number
- K182695
- Device name
- Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
- Applicant
- Cook Incorporated
- Decision
- Unknown
- Date received
- 2018-09-27
- Decision date
- 2019-06-17
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- EYB
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bloomington, IN, 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.
| Record | Firm | Date |
|---|---|---|
| RocaTub Ureteral Catheter (K192183) | Promepal Sam | 2020-04-23 |
| Dornier MINNOW Ureteral Catheter (K191187) | Dornier Medtech America, Inc. | 2019-09-18 |
| UPJ Occlusion Balloon Catheter (K183323) | Cook Incorporated | 2019-08-05 |
| Ureteric Catheters (K182122) | Coloplast Corp. | 2018-10-04 |
| Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter (K180182) | Cook Incorporated | 2018-09-14 |
| Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (K171043) | Coloplast Corp. | 2017-12-21 |
| OCCLUDER OCCLUSION BALLOON CATHETER (K133750) | Boston Scientific Corporation | 2014-01-08 |
| 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 Corporation | 2005-03-03 |
| 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
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |