FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOPERSURGICAL INFRARED COAGULATOR
K Number: K974168
·
Decision Jan 23, 1998
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
26
Review Days
79
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Basic Information
- Device Name
- COOPERSURGICAL INFRARED COAGULATOR
- K Number
- K974168
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hogan & Hartson
- Date Received
- November 5, 1997
- Decision Date
- January 23, 1998
- 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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| K946217 | CARDIOLIPIN M EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946216 | CARDIOLIPIN A EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946215 | CARDIOLIPIN G EIA TEST SYSTEM | Jan 24, 1996 | Substantially Equivalent |
| K946186 | CHAL-2500 | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K941566 | COMPUSPEAK | Jun 30, 1995 | Substantially Equivalent |
| K950110 | MARDX MITOCHONDRIA EIA TEST SYSTEM | May 15, 1995 | Substantially Equivalent |