Cleared Abbreviated

IUI CATHETER, MODEL 9057 (K052059) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K052059 · Inntec, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Nov 2005
Decision
116d
Days
Class 2
Risk

K052059 is an FDA 510(k) clearance for the IUI CATHETER, MODEL 9057. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Inntec, Inc. (Stoughton, US). The FDA issued a Cleared decision on November 22, 2005 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Inntec, Inc. devices

Submission Details

510(k) Number K052059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2005
Decision Date November 22, 2005
Days to Decision 116 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 160d · This submission: 116d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MQF Catheter, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
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 - MQF Catheter, Assisted Reproduction

All 52
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