FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROSIL; MAGIC; PERSONAL CATHETER
K Number: K122785
·
Decision May 14, 2013
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
81
Applicant Total
13
Review Days
245
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Basic Information
- Device Name
- HYDROSIL; MAGIC; PERSONAL CATHETER
- K Number
- K122785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rochester Medical Corp.
- Date Received
- September 11, 2012
- Decision Date
- May 14, 2013
- Product Code
- EZD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EZD | Catheter, Straight | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Rochester Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | Jun 10, 2004 | Substantially Equivalent |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | Jul 7, 2000 | Substantially Equivalent |
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) | May 19, 2000 | Substantially Equivalent |
| K981612 | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER | Jul 8, 1998 | Substantially Equivalent |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | Jan 13, 1998 | Substantially Equivalent |
| K970704 | PERSONAL CATHETER | Mar 13, 1997 | Substantially Equivalent |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER | Jul 18, 1995 | Substantially Equivalent |
| K941692 | FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER | Mar 6, 1995 | Substantially Equivalent |
| K943851 | ALL SILICONE INTERMITTENT CATHETER | Jan 31, 1995 | Substantially Equivalent |
| K923136 | MALE EXTERNAL CATHETER | Dec 3, 1992 | Substantially Equivalent |