FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Laport
K Number: K252985
·
Decision May 19, 2026
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
9
Review Days
243
Basic Information
- Device Name
- Laport
- K Number
- K252985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sejong Medical Co., Ltd.
- Date Received
- September 18, 2025
- Decision Date
- May 19, 2026
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
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Other Clearances by Sejong Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253165 | LAP-iX2N | Jun 9, 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 |
| 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 |