FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
LAP-iX
K Number: K200639
·
Decision Sep 29, 2021
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
9
Review Days
568
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Basic Information
- Device Name
- LAP-iX
- K Number
- K200639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sejong Medical Co., Ltd.
- Date Received
- March 10, 2020
- Decision Date
- September 29, 2021
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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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 |
| K200638 | LAP-iX Suction Irrigation | Apr 3, 2020 | Substantially Equivalent |
| K173108 | Smoklean | May 18, 2018 | Substantially Equivalent |
| K173111 | LAP-iX Suction Irrigation | Nov 28, 2017 | Substantially Equivalent |
| K173112 | LAP-iX | Nov 21, 2017 | Substantially Equivalent |
| K171726 | LapBag | Sep 25, 2017 | Substantially Equivalent |
| K171741 | Laport | Aug 29, 2017 | Substantially Equivalent |