FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LAP-iX Suction Irrigation
K Number: K173111
·
Decision Nov 28, 2017
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
9
Review Days
60
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Basic Information
- Device Name
- LAP-iX Suction Irrigation
- K Number
- K173111
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sejong Medical Co., Ltd.
- Date Received
- September 29, 2017
- Decision Date
- November 28, 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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Other Clearances by Sejong Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253165 | LAP-iX2N | Jun 9, 2026 | Substantially Equivalent |
| K252985 | Laport | May 19, 2026 | Substantially Equivalent |
| K200639 | LAP-iX | Sep 29, 2021 | Substantially Equivalent |
| K200638 | LAP-iX Suction Irrigation | Apr 3, 2020 | Substantially Equivalent |
| K173108 | Smoklean | May 18, 2018 | Substantially Equivalent |
| K173112 | LAP-iX | Nov 21, 2017 | Substantially Equivalent |
| K171726 | LapBag | Sep 25, 2017 | Substantially Equivalent |
| K171741 | Laport | Aug 29, 2017 | Substantially Equivalent |