Cleared Traditional

K231725 - Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231725 · Hunan Endoso Life Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
125d
Days
Class 2
Risk

K231725 is an FDA 510(k) clearance for the Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R). Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Hunan Endoso Life Technology Co., Ltd. (Hunan, CN). The FDA issued a Cleared decision on October 16, 2023 after a review of 125 days - within the typical 510(k) review window.

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 Hunan Endoso Life Technology Co., Ltd. devices

Submission Details

510(k) Number K231725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2023
Decision Date October 16, 2023
Days to Decision 125 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
11d slower than avg
Panel avg: 114d · This submission: 125d
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 1414
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K231725.
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
K252858 · Kms Medical Technology Co., Ltd. · Apr 2026
Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
K260197 · Suzhou Shenyun Medical Equipment Co., Ltd. · Apr 2026
TL-10 Laparoscopic Scope Cleaner
K260089 · Scopix , Ltd. · Apr 2026
C-Lant Port
K252714 · Vigor Medical Technologies , Ltd. · Feb 2026
Universal Seal (5-12 mm)
K253978 · Intuitive Surgical, Inc. · Feb 2026
1688 4K Camera System with Advanced Imaging Modality
K260185 · Stryker Endoscopy · Feb 2026