FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERCUTANEOUS SURAPUBIC CATHETER
K Number: K780765
·
Decision Jul 17, 1978
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
31
Applicant Total
17
Review Days
73
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Basic Information
- Device Name
- PERCUTANEOUS SURAPUBIC CATHETER
- K Number
- K780765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Vance Products, Inc.
- Date Received
- May 5, 1978
- Decision Date
- July 17, 1978
- Product Code
- KOB
- 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 |
|---|---|---|---|
| KOB | Catheter, Suprapubic (And Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOB), ordered by most recent decision date.
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SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
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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 |