FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPEC 5* SUPRAPUBIC CATHETER
K Number: K881097
·
Decision Jun 3, 1988
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
31
Applicant Total
18
Review Days
80
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Basic Information
- Device Name
- SPEC 5* SUPRAPUBIC CATHETER
- K Number
- K881097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Porges Corp.
- Date Received
- March 15, 1988
- Decision Date
- June 3, 1988
- 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
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Other Clearances by Porges Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K900269 | PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE | Jul 3, 1990 | Substantially Equivalent |
| K900031 | MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS | Mar 6, 1990 | Substantially Equivalent |
| K896503 | PORGES ERCP CATHETERS | Jan 30, 1990 | Substantially Equivalent |
| K896505 | PORGES UNIVERSAL HANDLES | Jan 30, 1990 | Substantially Equivalent |
| K896425 | PORGES CYTOLOGY BRUSHES | Jan 29, 1990 | Substantially Equivalent |
| K896507 | PORGES DIATHERMY SNARE | Jan 29, 1990 | Substantially Equivalent |
| K896504 | PORGES 2-WAY BALLOON EXTRACTION CATHETER | Jan 26, 1990 | Substantially Equivalent |
| K896424 | PORGES SCLEROTHERAPY NEEDLES | Jan 26, 1990 | Substantially Equivalent |
| K896506 | PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR | Jan 26, 1990 | Substantially Equivalent |
| K896423 | PORGES BILIARY STENTS | Jan 22, 1990 | Substantially Equivalent |