Cleared Special

PIPET CURET (K001545) - FDA 510(k) Clearance

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

K001545 · Milex Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
28d
Days
Class 2
Risk

K001545 is an FDA 510(k) clearance for the PIPET CURET. Classified as Curette, Suction, Endometrial (and Accessories) (product code HHK), Class II - Special Controls.

Submitted by Milex Products, Inc. (Chicago, US). The FDA issued a Cleared decision on June 15, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1175 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Milex Products, Inc. devices

Submission Details

510(k) Number K001545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2000
Decision Date June 15, 2000
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 160d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HHK Curette, Suction, Endometrial (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1175
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 - HHK Curette, Suction, Endometrial (and Accessories)

All 41
Devices cleared under the same product code (HHK) and FDA review panel - the closest regulatory comparables to K001545.
Uterine Aspiration Set
K251882 · Gcmedica Enterprise Ltd.(Wuxi) · Oct 2025
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
K240434 · Li Medical Corporation , Ltd. · Sep 2024
CrossGlide ETS Plus
K201952 · Crossbay Medical · Aug 2020
CrossBay Endometrial Tissue Sampler (ETS)
K192534 · Crossbay Medical · Mar 2020
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K771149 · C.R. Bard, Inc. · Jul 1977