COMFORT SLEEVED ALL SILICONE FOLEY CATHETER— 510(k) K905042
Substantially EquivalentRochester Medical Corp.
FDA 510(k) clearance K905042 for COMFORT SLEEVED ALL SILICONE FOLEY CATHETER, Substantially Equivalent on 1991-01-18. Applicant: Rochester Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Rochester Medical Corp.
- Product code
- Code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stewartville, MN, US
Recent devices under product code EZL
view allMore clearances from Rochester Medical Corp.
view all- K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER
- K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
- K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
- K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
- K981612 — ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
Adverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.