FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
TROKAMED MORCELLATOR
K Number: K091010
·
Decision Mar 1, 2011
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
4
Review Days
691
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Basic Information
- Device Name
- TROKAMED MORCELLATOR
- K Number
- K091010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trokamed GmbH
- Date Received
- April 9, 2009
- Decision Date
- March 1, 2011
- Product Code
- HET
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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