FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
K Number: K951260
·
Decision Sep 27, 1995
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
70
Review Days
190
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Basic Information
- Device Name
- URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
- K Number
- K951260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biosearch Medical Products, Inc.
- Date Received
- March 21, 1995
- Decision Date
- September 27, 1995
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Biosearch Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051480 | ENTERAL FEEDING TUBE | Oct 12, 2005 | Substantially Equivalent |
| K970145 | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) | Aug 11, 1997 | Substantially Equivalent |
| K964871 | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS | Mar 3, 1997 | Substantially Equivalent |
| K944614 | MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM | Apr 5, 1995 | Substantially Equivalent |
| K932295 | NON-BALLOON REPLACEMENT GASTROSTOMY KIT | Sep 8, 1994 | Substantially Equivalent |
| K935045 | BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER | Aug 19, 1994 | Substantially Equivalent |
| K923002 | ENTEROCLYSIS TUBE | Jun 28, 1994 | Unknown |
| K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST | Nov 19, 1993 | Substantially Equivalent |
| K922987 | LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC. | Apr 23, 1993 | Substantially Equivalent |
| K923474 | LOW PROFILE GASTROMSTOMY DEVICE | Jan 5, 1993 | Unknown |