Cleared Traditional

K111441 - UNIMAX VERESS NEEDLE

K111441 is an FDA 510(k) clearance for UNIMAX VERESS NEEDLE, manufactured by Unimax Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K111441 · Unimax Medical Systems, Inc. · Obstetrics & Gynecology device
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Aug 2011
Decision
87d
Days
Class 2
Risk

K111441 is an FDA 510(k) clearance for the UNIMAX VERESS NEEDLE. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Unimax Medical Systems, Inc. (Taipei County, TW). The FDA issued a Cleared decision on August 19, 2011 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Unimax Medical Systems, Inc. devices

FDA 510(k) Submission Details - K111441

510(k) Number K111441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2011
Decision Date August 19, 2011
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 161d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 144
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K111441.
HIGH FLOW INSUFFLATION UNIT UHI-4
K110294 · Olympus Medical Systems Corporation · Nov 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
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VESSEL GUARDIAN
K112357 · Lexion Medical, LLC · Nov 2011
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K103692 · Surgiquest, Inc. · May 2011
VESSEL GUARDIAN
K102136 · Lexion Medical, LLC · Sep 2010
VASOVAPOR
K101320 · Lexion Medical, LLC · Jun 2010