Cleared Traditional

K252985 - Laport

K252985 is an FDA 510(k) clearance for Laport, manufactured by Sejong Medical Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K252985 · Sejong Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
243d
Days
Class 2
Risk

K252985 is an FDA 510(k) clearance for the Laport. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Sejong Medical Co., Ltd. (Paju-Si, KR). The FDA issued a Cleared decision on May 19, 2026 after a review of 243 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sejong Medical Co., Ltd. devices

FDA 510(k) Submission Details - K252985

510(k) Number K252985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2025
Decision Date May 19, 2026
Days to Decision 243 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 115d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 1045
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K252985.
Inno-Port Disposable Bladed Trocar
K252532 · Taiwan Surgical Corporation · Jun 2026
4K NIR/ICG Imaging System
K260318 · Zhejiang Healnoc Technology Co., Ltd. · May 2026
MediBot Needle Driver Uno
K260183 · Parallel Robotics, LLC · May 2026
KARL STORZ Trocars with Valve Seals
K254228 · Karl Storz SE & CO. KG · May 2026
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
K252858 · Kms Medical Technology Co., Ltd. · Apr 2026
TL-10 Laparoscopic Scope Cleaner
K260089 · Scopix , Ltd. · Apr 2026