Cleared Special

K001545 - PIPET CURET

K001545 is an FDA 510(k) clearance for PIPET CURET, manufactured by Milex Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHK cleared through the Special 510(k) pathway after a 28-day FDA review.

K001545 · Milex Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K001545

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 161d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HHK Device Classification - Class 2, Special Controls

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.
MAS WITH OR WITHOUT SYRINGE
K021876 · Marina Medical Instruments, Inc. · Apr 2003
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
K020628 · Bioteque America, Inc. · May 2002
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
K001555 · Sims Portex , Ltd. · Aug 2000
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974 · Utah Medical Products, Inc. · May 2000
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
K000026 · Apple Medical Corp. · Mar 2000
GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
K992926 · Ri Mos. S.R.L. · Oct 1999
K001545 · PIPET CURET
Download PDF FDA Summary Milex Products, Inc.