Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Uresil Corp. — Predicate Candidate Screening

45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

81 daysmedian FDA review time
298 days90th percentile
45clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHEUresil Corp.2001-01-04300
K980278URESIL VASCU-FLO INFUSION CATHETERUresil Corp.1998-11-202980
K981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATUresil Corp.1998-09-101540
K980282URESIL DILATOR WITH RADIOPAQUE MARKERUresil Corp.1998-04-24880
K980889URESIL NEPHRO-URETERAL STENTUresil Corp.1998-04-08300
K972582URESIL GUIDEWIREUresil Corp.1997-11-211340
K972583URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMYUresil Corp.1997-08-29500
K953923URESIL INTRODUCING NEEDLEUresil Corp.1995-09-08210
K945934URESIL(R) GUIDEWIREUresil Corp.1995-07-102170
K942688NEPHRO-URETERAL STENTUresil Corp.1995-06-063640
K944784MINI-OP LAPAROSCOPIC LASSOUresil Corp.1994-10-28310
K942191URESIL DILATORUresil Corp.1994-09-211400
K940505ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)Uresil Corp.1994-06-211380
K921417URESIL LAPAROSCOPIC RETRACTORUresil Corp.1993-10-085630
K925117URESIL ABSCESS DRIANAGE AND IRRIGATION SETUresil Corp.1993-08-113060
K923096URESIL BILLIARY CATHETERUresil Corp.1993-07-133830
K930011URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADSUresil Corp.1993-05-261420
K923219URESIL SPECIMEN RETRIEVAL BAGUresil Corp.1992-12-151670
K923097URESIL NEPHROSTOMY CATHETERUresil Corp.1992-09-14810
K920509URESIL SUMP DRAINAGE CATHETERUresil Corp.1992-09-142230
K920510URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETERUresil Corp.1992-09-142250
K915343URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERUresil Corp.1992-03-311260
K914699URESIL FIXATION DEVICEUresil Corp.1992-02-191240
K912109URESIL GENERAL PURPOSE DRAINAGE CATHETERUresil Corp.1991-08-12910
K905528URESIL VALVE CUTTERUresil Corp.1991-04-181290
K903449URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SETUresil Corp.1990-09-12440
K901882URESIL ENDOSCOPIC LASER OVERTUBEUresil Corp.1990-07-27920
K901844URESIL TRU-CLOSE DRAINAGE BAGUresil Corp.1990-06-01380
K880895URESIL WOUND DRAIN TROCARUresil Corp.1988-03-14120
K872948URESIL THORA-FLO THORACENTESIS PROCEDURE KITUresil Corp.1987-11-271220
K872788MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMENUresil Corp.1987-09-25730
K871148URESIL CAROTID ARTERY SIZERSUresil Corp.1987-04-22300
K870141URESIL T-SYSTEM BONE SCREWSUresil Corp.1987-02-03210
K863684URESIL SUBCLAVIAN CATHETERUresil Corp.1987-01-061090
K864007EMBOLECTOMY/THROMBECTOMY BALLOON CATHETERUresil Corp.1987-01-02790
K863558URESIL CAROTID SHUNTUresil Corp.1986-11-24730
K863571BILIARY BALLOON CATHETERUresil Corp.1986-11-04530
K863564URESIL IRRIGATION CATHETERUresil Corp.1986-10-10280
K863559URESIL OCCLUSION BALLOON CATHETERUresil Corp.1986-10-10280
K863563URESIL RADIOPAQUE SILICONE BANDSUresil Corp.1986-10-02200
K863560URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRAUresil Corp.1986-09-29170
K863562URESIL 150CC BELLOWS RESERVOIRUresil Corp.1986-09-29170
K863561URESIL THORACIC VENTUresil Corp.1986-09-23110
K863505URESIL CLOSED DRAINAGE RESERVOIRUresil Corp.1986-09-1890
K812640URE SIL EMBOLECTOMY/THROMBECTOMY CATHUresil Corp.1981-10-02160

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda