FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
LAP-Pump PP110
K Number: K163320
·
Decision Mar 21, 2017
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
26
Review Days
118
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Basic Information
- Device Name
- LAP-Pump PP110
- K Number
- K163320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W.O.M. World of Medicine GmbH
- Date Received
- November 23, 2016
- Decision Date
- March 21, 2017
- 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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| K011175 | W.O.M. LASER U100 | Nov 1, 2001 | Substantially Equivalent |
| K000153 | ARTHRO-SURGIMAT-A103 | Feb 8, 2000 | Substantially Equivalent |