Cleared Traditional

Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) (K250124) - FDA 510(k) Clearance

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

K250124 · Hangzhou Viction Medical Technology Co.,Ltd · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
201d
Days
Class 2
Risk

K250124 is an FDA 510(k) clearance for the Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, V.... Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Hangzhou Viction Medical Technology Co.,Ltd (Hangzhou, CN). The FDA issued a Cleared decision on August 6, 2025 after a review of 201 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 Hangzhou Viction Medical Technology Co.,Ltd devices

Submission Details

510(k) Number K250124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2025
Decision Date August 06, 2025
Days to Decision 201 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
86d slower than avg
Panel avg: 115d · This submission: 201d
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 438
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K250124.
Revolve Surgical System
K243968 · Revolve Surgical, Inc. · Oct 2025
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
K250551 · Shenzhen Sophway Technology Co., Ltd. · Oct 2025
SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
K251743 · Surgical Principals, Inc. · Sep 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
Disposable Trocars
K250820 · Sinolinks Medical Innovation, Inc. · Jul 2025