FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYRUS ACMI BIOCOAG PROBE
K Number: K092571
·
Decision Oct 20, 2010
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
42
Review Days
425
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Basic Information
- Device Name
- GYRUS ACMI BIOCOAG PROBE
- K Number
- K092571
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gyrus Acmi, Inc.
- Date Received
- August 21, 2009
- Decision Date
- October 20, 2010
- 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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