Cleared Traditional

K241402 - Medical Monitor (32HR734S)

K241402 is the FDA 510(k) clearance for Medical Monitor (32HR734S) by Lg Electronics.Inc. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K241402 · Lg Electronics.Inc · General & Plastic Surgery device
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Aug 2024
Decision
87d
Days
Class 2
Risk

K241402 is an FDA 510(k) clearance for the Medical Monitor (32HR734S). Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Lg Electronics.Inc (Gumi-Si, KR). The FDA issued a Cleared decision on August 12, 2024 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lg Electronics.Inc devices

Submission Details

510(k) Number K241402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2024
Decision Date August 12, 2024
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 677
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K241402.
TroCare TroKit Laparoscope Lens Wiper (CP000626)
K241796 · TroCare, LLC · Oct 2024
da Vinci Handheld Camera
K241913 · Intuitive Surgical Operations, Inc. · Aug 2024
Connected OR Hub with Device and Voice Control
K241401 · Stryker Endoscopy · Aug 2024
Stellar Imaging System
K241530 · Guangdong Optomedic Technologies, Inc. · Aug 2024
Universal Seal (5-12 mm)
K241360 · Intuitive Surgical, Inc. · Aug 2024
Arthrex Synergy Vision Endoscopic Imaging System
K241361 · Arthrex, Inc. · Jul 2024