Cleared Traditional

K250130 - Viction Disposable Irrigation and sucti...

Also marketed or referenced as:
VC-FLA0523 VC-FLA0532 VC-FLB0514 VC-FLB0523 VC-FLB0532 VC-FLC0514 VC-FLC0523 VC-FLC0532 VC-FLD0514 VC-FLD0523 VC-FLD0532)

K250130 is an FDA 510(k) clearance for Viction Disposable Irrigation and sucti..., manufactured by Hangzhou Viction Medical Technology 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 201-day FDA review.

K250130 · 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

K250130 is an FDA 510(k) clearance for the Viction Disposable Irrigation and suction System (VC-FLA0514. 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

FDA 510(k) Submission Details - K250130

510(k) Number K250130 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.

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 802
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K250130.
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 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
SPY Laparoscope
K252010 · Stryker Endoscopy · Jul 2025
Disposable Trocars
K250820 · Sinolinks Medical Innovation, Inc. · Jul 2025
Boehringer Laboratories Liver Retractor
K243399 · Boehringer Laboratories, LLC · Jul 2025