FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLLACK CHAIN CYSOURETHROGRAM SET
K Number: K810370
·
Decision Mar 20, 1981
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
17
Review Days
36
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Basic Information
- Device Name
- POLLACK CHAIN CYSOURETHROGRAM SET
- K Number
- K810370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Vance Products, Inc.
- Date Received
- February 12, 1981
- Decision Date
- March 20, 1981
- Product Code
- FGI
- 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 |
|---|---|---|---|
| FGI | Catheter, Urethrographic, Male | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGI), ordered by most recent decision date.
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DFINER UROLOGICAL CATHETER
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 |
| K810368 | VANCE PERCUTANEOUS MALECOT NEPHROSTOMY | Mar 20, 1981 | Substantially Equivalent |
| K810372 | VANCE DEFLECTABLE BIOPSY BRUSH SET | Mar 20, 1981 | Substantially Equivalent |