FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORGES DIATHERMY SNARE
K Number: K896507
·
Decision Jan 29, 1990
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
18
Review Days
75
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Basic Information
- Device Name
- PORGES DIATHERMY SNARE
- K Number
- K896507
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Porges Corp.
- Date Received
- November 15, 1989
- Decision Date
- January 29, 1990
- Product Code
- KNS
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
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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 |
| 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 |
| K896376 | PORGES NASOBILIARY DRAIN | Jan 22, 1990 | Substantially Equivalent |