FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K Number: K880748
·
Decision Aug 4, 1988
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
104
Review Days
162
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Basic Information
- Device Name
- BALL TIP FULGURATING ELECTRODE, 3 FRENCH
- K Number
- K880748
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cook Urological, Inc.
- Date Received
- February 24, 1988
- Decision Date
- August 4, 1988
- 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 |
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|---|---|---|---|
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| K073496 | OPTILITE HOLMIUM LASER FIBERS | Jan 23, 2008 | Substantially Equivalent |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | Aug 17, 2006 | Substantially Equivalent |