Cleared Traditional

K103509 - UNIMAX SUCTION IRRIGATION SET

K103509 is an FDA 510(k) clearance for UNIMAX SUCTION IRRIGATION SET, manufactured by Unimax Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K103509 · Unimax Medical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
171d
Days
Class 2
Risk

K103509 is an FDA 510(k) clearance for the UNIMAX SUCTION IRRIGATION SET. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Unimax Medical Systems, Inc. (Taipei County, TW). The FDA issued a Cleared decision on May 19, 2011 after a review of 171 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 Unimax Medical Systems, Inc. devices

FDA 510(k) Submission Details - K103509

510(k) Number K103509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2010
Decision Date May 19, 2011
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
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 1174
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K103509.
THE ESPINER SAC OR E SAC
K111845 · Espiner Medical Limited · Sep 2011
VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
K112349 · Covidien, Formerly US Surgical A Divison of Tyco H · Sep 2011
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
K101733 · Sac, LLC Dba Pinnacle Medical Surgical · Jun 2011
WEXLER ENDOSCOPE ACCESSORIES
K110121 · Microsurgical Laboratories,Inc.Dba Wexler Surgical · May 2011
UNIMAX SPECIMEN RETRIEVAL SYSTEM
K103510 · Unimax Medical Systems, Inc. · May 2011
DIAMOND-FLEX(R) GRASPERS
K110257 · Carefusion 2200, Inc. · May 2011