Cleared Traditional

K250820 - Disposable Trocars

K250820 is an FDA 510(k) clearance for Disposable Trocars, manufactured by Sinolinks Medical Innovation, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K250820 · Sinolinks Medical Innovation, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
115d
Days
Class 2
Risk

K250820 is an FDA 510(k) clearance for the Disposable Trocars. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Sinolinks Medical Innovation, Inc. (Changzhou, Jiangsu, CN). The FDA issued a Cleared decision on July 11, 2025 after a review of 115 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 Sinolinks Medical Innovation, Inc. devices

FDA 510(k) Submission Details - K250820

510(k) Number K250820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2025
Decision Date July 11, 2025
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
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 803
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K250820.
Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)
K250124 · Hangzhou Viction Medical Technology Co.,Ltd · Aug 2025
Viction Disposable Irrigation and suction System (VC-FLA0514
K250130 · Hangzhou Viction Medical Technology Co.,Ltd · Aug 2025
SPY Laparoscope
K252010 · Stryker Endoscopy · Jul 2025
Boehringer Laboratories Liver Retractor
K243399 · Boehringer Laboratories, LLC · Jul 2025
8 mm Assist Cannula
K251490 · Intuitive Surgical, Inc. · Jul 2025
Medical Monitor (32HS710S)
K251209 · Lg Electronics.Inc · Jun 2025