510(k) K021856
- Device
- PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
- Applicant
- PORGES S.A.
- 510(k) number
- K021856
- Product code
- EYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-17
- Date received
- 2002-06-06
- Regulation
- 876.5130
- Classification name
- Catheter, Ureteral, Gastro-urology
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BERNARD ISMAEL
- Address
- Centre D'Affaires La Boursidiere Le Plessis Robinson Cedex FR 92357 92357
FDA Registration Numbers#
- 3012649202
- 1825146
- 2027111
- 3008502431
- 1018233
- 3012445205
- 9616684
- 3003903031
- 3002807314
- 3005669815
- 1417592
- 3014579161
- 3005099803
- 3005515211
- 3004070478
- 3009051888
- 3016761372
- 3011050570
- 3007156625
- 1647149
- 9610711
- 9617592
- 1037955
- 3000268902
- 1000393132
- 1313046
- 9611590
- 3003814961
- 3010400865
- 3006082230
- 1820334
- 3003915875
- 3005941719
- 1646831
- 3027301746
- 3001124136
- 9681477
- 3010155661
- 2124215
- 3009763019
- 3012050423
- 2183744
- 3016096097
- 3003790304
Source Documents#
Other 510(k) Records For Product Code EYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192183 | RocaTub Ureteral Catheter | Promepal Sam | 2020-04-23 |
| K191187 | Dornier MINNOW Ureteral Catheter | Dornier Medtech America, Inc. | 2019-09-18 |
| K183323 | UPJ Occlusion Balloon Catheter | Cook Incorporated | 2019-08-05 |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | Cook Incorporated | 2019-06-17 |
| K182122 | Ureteric Catheters | Coloplast Corp. | 2018-10-04 |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | Cook Incorporated | 2018-09-14 |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters | Coloplast Corp. | 2017-12-21 |
| K133750 | OCCLUDER OCCLUSION BALLOON CATHETER | Boston Scientific Corporation | 2014-01-08 |
| K092250 | MEDLINE RED RUBBER URETHRAL CATHETER | Medline Industries, Inc. | 2010-01-21 |
| K083788 | ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR | Endooptiks, Inc. | 2009-03-03 |
| K043581 | DUAL LUMEN CATHETER | Acmi Corporation | 2005-03-03 |
| K030293 | AMSURE RED RUBBER URETHRAL CATHETER | Amsino International, Inc. | 2004-02-04 |
| K033368 | FOSSA URETERAL OPEN LUMEN STENT | Fossa Medical, Inc. | 2003-11-26 |
| K032521 | BARD DUAL LUMEN URETERAL CATHETER | C.R. Bard, Inc. | 2003-11-14 |
| K020577 | APPLIED URETERAL CATHETER | Applied Medical Resources Corp. | 2002-05-22 |
Legacy Summary#
summary
FDA Review#
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