FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANCE MALLEABLE TIP FILIFORM
K Number: K792219
·
Decision Dec 6, 1979
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
26
Applicant Total
17
Review Days
31
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
- VANCE MALLEABLE TIP FILIFORM
- K Number
- K792219
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Vance Products, Inc.
- Date Received
- November 5, 1979
- Decision Date
- December 6, 1979
- 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 Vance Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K820313 | VPI-FAIR URETHRAL STENT | Mar 1, 1982 | Substantially Equivalent |
| K812995 | VANCE-JACOBELLIS MICROHEMATURIA CATHETER | Mar 1, 1982 | Substantially Equivalent |
| K813278 | VPI URETERAL DILATATION BALLON CATHETER | Dec 18, 1981 | Substantially Equivalent |
| K812785 | VANCE-AMBROSE RESECTOSCOPE FORCEPS | Nov 16, 1981 | Substantially Equivalent |
| K812057 | VANCE CYSTOSCOPIC | Jul 31, 1981 | Substantially Equivalent |
| K811833 | VNACE FASCIAL DILATOR SET | Jul 10, 1981 | Substantially Equivalent |
| K811454 | VANCE PROSTATIC ASPIRATION SET | Jun 9, 1981 | Substantially Equivalent |
| K810367 | KISH URETHRAL ILLUMINATED CATHETER SET | Mar 20, 1981 | Substantially Equivalent |
| K810370 | POLLACK CHAIN CYSOURETHROGRAM SET | Mar 20, 1981 | Substantially Equivalent |
| K810368 | VANCE PERCUTANEOUS MALECOT NEPHROSTOMY | Mar 20, 1981 | Substantially Equivalent |