FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K Number: K901603
·
Decision May 4, 1990
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
31
Applicant Total
50
Review Days
38
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Basic Information
- Device Name
- MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
- K Number
- K901603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Bivona Medical Technologies
- Date Received
- March 27, 1990
- Decision Date
- May 4, 1990
- 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 Bivona Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K952700 | SUPERSLICK | Oct 31, 1995 | Substantially Equivalent |
| K942025 | BURGET NASAL STENT | Oct 27, 1995 | Substantially Equivalent |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | Oct 27, 1994 | Substantially Equivalent |
| K935053 | BIVONA NASAL TURBINATE STENT | Jul 1, 1994 | Substantially Equivalent |
| K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE | Oct 6, 1993 | Substantially Equivalent |
| K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE | Aug 10, 1993 | Substantially Equivalent |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | Jan 7, 1993 | Substantially Equivalent |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | Dec 29, 1992 | Substantially Equivalent |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | Jul 27, 1992 | Substantially Equivalent |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | Jun 29, 1992 | Substantially Equivalent |