FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSTATIC URETHRO. BALLOON DILATATION CATHETER
K Number: K873295
·
Decision Jul 31, 1989
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
26
Applicant Total
36
Review Days
714
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROSTATIC URETHRO. BALLOON DILATATION CATHETER
- K Number
- K873295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Tech, Inc.
- Date Received
- August 17, 1987
- Decision Date
- July 31, 1989
- Product Code
- KOE
- 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 |
|---|---|---|---|
| KOE | Dilator, Urethral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOE), ordered by most recent decision date.
Optilume Basic Urological Balloon Dilation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ATRION MEDICAL QL INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BARD EAGLE INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AQ HYDROPHILIC DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
U.S. MEDICAL PS-7000 DIALYSIS SCALE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Medi-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | May 15, 1996 | Substantially Equivalent |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | Aug 17, 1995 | Substantially Equivalent |
| K952056 | IMMUNOASSAY DRUGS OF ABUSE CONTROLS | Jun 1, 1995 | Substantially Equivalent |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | Dec 13, 1994 | Substantially Equivalent |
| K942551 | THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED | Oct 6, 1994 | Substantially Equivalent |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | Sep 14, 1994 | Substantially Equivalent |
| K922990 | HEMODIALYSIS BATH | Sep 12, 1994 | Substantially Equivalent |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | Sep 9, 1994 | Substantially Equivalent |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Oct 22, 1990 | Substantially Equivalent |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | Nov 2, 1989 | Substantially Equivalent for Some Indications |