Cleared Traditional

K033589 - BAXTER DUPLOTIP SURGICAL SEALANT APPLIC...

K033589 is the FDA 510(k) clearance for BAXTER DUPLOTIP SURGICAL SEALANT APPLIC... by Micromedics, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K033589 · Micromedics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
326d
Days
Class 2
Risk

K033589 is an FDA 510(k) clearance for the BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on October 4, 2004 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Micromedics, Inc. devices

Submission Details

510(k) Number K033589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2003
Decision Date October 04, 2004
Days to Decision 326 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 129d · This submission: 326d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.

Regulatory Peers - FMF Syringe, Piston

All 286
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K033589.
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · Synthes (Usa) · Jul 2005
STRYKER DISCMONITOR
K050753 · Stryker Instruments · May 2005
1BD SOLOSHOT IX SYRINGE
K042934 · Becton, Dickinson & CO · Oct 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · Smith & Nephew, Inc. · Aug 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004
MERIT MEDICAL 1-ML SYRINGE
K024052 · Merit Medical Systems, Inc. · Feb 2003