FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTERIC FEEDING TUBE W/SEGM. FLEX. WT.
K Number: K801558
·
Decision Jul 28, 1980
Classifications
1
FEI Numbers
242
Registration Numbers
243
Same Product Code
648
Applicant Total
70
Review Days
20
Basic Information
- Device Name
- ENTERIC FEEDING TUBE W/SEGM. FLEX. WT.
- K Number
- K801558
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- BIOSEARCH MEDICAL PRODUCTS, INC.
- Date Received
- July 8, 1980
- Decision Date
- July 28, 1980
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 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 |
| K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | Sep 27, 1995 | 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 |