FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLONIC BALLOON DILATOR
K Number: K901426
·
Decision Jun 21, 1990
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
4
Applicant Total
22
Review Days
87
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Basic Information
- Device Name
- COLONIC BALLOON DILATOR
- K Number
- K901426
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5450
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Telemed Systems, Inc.
- Date Received
- March 26, 1990
- Decision Date
- June 21, 1990
- Product Code
- FFP
- 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 |
|---|---|---|---|
| FFP | Dilator, Rectal | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFP), ordered by most recent decision date.
ANOKRYO
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INAMED RHEMO-D (TM) DILATOR
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COLONIC BALLOON DIALATORS
FDA 510(k)
FDA Class 1
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COLORECTAL DILATOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Telemed Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020379 | PPD BALLOON DILATATION CATHETER | May 6, 2002 | Substantially Equivalent |
| K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | Mar 1, 2002 | Substantially Equivalent |
| K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | Apr 2, 2001 | Substantially Equivalent |
| K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | Dec 22, 1999 | Substantially Equivalent |
| K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | Dec 22, 1999 | Substantially Equivalent |
| K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | Jan 21, 1998 | Substantially Equivalent |
| K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | Dec 19, 1997 | Substantially Equivalent |
| K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | Jul 16, 1990 | Substantially Equivalent |
| K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | Jun 22, 1990 | Substantially Equivalent |
| K901425 | PYLORIC BALLOON DILATOR | Jun 21, 1990 | Substantially Equivalent |