FDA Product Code
FDA Product Code EZL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 130 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K964575 | SYMPACATH HYDROGEL COATED FOLEY | Rusch Intl. | 1997-02-04 | Traditional | PDF ↗ |
| K961697 | OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE | Medical Device Intl., Inc. | 1996-08-30 | Traditional | PDF ↗ |
| K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | Regulatory & Marketing Services, Inc. | 1996-04-10 | Traditional | PDF ↗ |
| K944676 | MRI'S ALL SILICONE FOLEY CATHETER | Mri Manufacturing and Research, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER | Regulatory & Marketing Services, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K944007 | EUROPHILIC SLIPPERY COATED FOLEY CATHETER | Baxter Healthcare Corp | 1995-06-29 | Traditional | PDF ↗ |
| K951106 | SILICONE FOLEY CATHETER | Cook Urological, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K951103 | SILASTIC BRAND FOLEY CATHETER | C.R. Bard, Inc. | 1995-04-28 | Traditional | PDF ↗ |
| K945806 | SILICATH ALL SILICONE FOLEY CATHETER | Unomedical Sdn Bhd | 1995-03-21 | Traditional | PDF ↗ |
| K941692 | FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER | Rochester Medical Corp. | 1995-03-06 | Traditional | PDF ↗ |
| K944382 | ORION ALL SILICONE FOLEY CATHETER | Regulatory & Marketing Services, Inc. | 1994-12-06 | Traditional | PDF ↗ |
| K944380 | ORION FOLEY CATHETER | Regulatory & Marketing Services, Inc. | 1994-11-30 | Traditional | PDF ↗ |
| K944376 | ORION ALL SILICONE ELASTOMER COATED CATHETER | Regulatory & Marketing Services, Inc. | 1994-11-30 | Traditional | PDF ↗ |
| K944381 | ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | Regulatory & Marketing Services, Inc. | 1994-11-30 | Traditional | PDF ↗ |
| K941488 | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER | Medical Technology Development Corp. | 1994-11-30 | Traditional | PDF ↗ |
| K934895 | GLASSMAN SILICONE CATHETER | Axiom Medical, Inc. | 1994-10-13 | Traditional | PDF ↗ |
| K935630 | NORTA | Beiersdorf, Inc. | 1994-10-07 | Traditional | PDF ↗ |
| K930344 | SILICONE FOLEY CATHETER | Cook Urological, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K932809 | FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR | Excalibur Engineering Care of Rms, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K911617 | UROTECH CATHETER | Urotech U.S.A., Inc. | 1993-02-25 | Traditional | PDF ↗ |
| K922821 | YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES | Yellow Springs Instrument Co., Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K921561 | YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES | Ysis, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K905042 | COMFORT SLEEVED ALL SILICONE FOLEY CATHETER | Rochester Medical Corp. | 1991-01-18 | Traditional | PDF ↗ |
| K903777 | WRP FOLEYCATH | Wembley Rubber Products (M) Sdn Bhd | 1990-12-13 | Traditional | PDF ↗ |
| K902710 | FOLEY CATHETER | Societa Gruppi Elastomeri S.A. | 1990-11-21 | Traditional | PDF ↗ |
| K894883 | PHYCON ALL SILICONE BALLOON CATHETER | Vitaid, Ltd. | 1990-04-25 | Traditional | PDF ↗ |
| K810691 | CURITY 100% SILICONE IRRIGATION FOLEY | The Kendal Co. | 1981-03-13 | Traditional | PDF ↗ |
| K780062 | CATHETER/HEMOSTATIC/GERIATRIC | Kendall Research Center | 1978-02-14 | Traditional | PDF ↗ |
| K772218 | CATHETER, SILICONE COATED | Concord Laboratories, Inc. | 1977-12-13 | Traditional | PDF ↗ |
| K771860 | FOLHY CATHETER | Polysil, Inc. | 1977-10-18 | Traditional | PDF ↗ |
Product code EZL · Class II · Gastroenterology, Urology. Data: openFDA.