Cleared Traditional

K233069 - Removal System Large Bore 60 cc Syringe

K233069 is an FDA 510(k) clearance for Removal System Large Bore 60 cc Syringe, manufactured by Inari Medical, Inc.. The device is a Class 2 General Hospital device with product code PUR cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K233069 · Inari Medical, Inc. · General Hospital
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Mar 2024
Decision
182d
Days
Class 2
Risk

K233069 is an FDA 510(k) clearance for the Removal System Large Bore 60 cc Syringe. Classified as Vacuum Syringe (product code PUR), Class II - Special Controls.

Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on March 26, 2024 after a review of 182 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Inari Medical, Inc. devices

FDA 510(k) Submission Details - K233069

510(k) Number K233069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date March 26, 2024
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PUR Device Classification - Class 2, Special Controls

Product Code PUR Vacuum Syringe
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition The Vacuum Syringe Is Intended To Be Used As A General Purpose Syringe For Injection And Withdrawal Of Fluids And Can Be Locked In Place To Create A Vacuum For Removal Of Fluid And/or Tissue From The Body In The Form Of Thrombus, Abscess Fluid, And Infected Fluid.
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 Hospital devices follow this clearance model.