Cleared Special

K171440 - Berkeley VC-10 Vacuum Curettage System

K171440 is an FDA 510(k) clearance for Berkeley VC-10 Vacuum Curettage System, manufactured by Gyrus Acmi. The device is a Class 2 Obstetrics & Gynecology device with product code HHI cleared through the Special 510(k) pathway after a 136-day FDA review.

K171440 · Gyrus Acmi · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
136d
Days
Class 2
Risk

K171440 is an FDA 510(k) clearance for the Berkeley VC-10 Vacuum Curettage System. Classified as System, Abortion, Vacuum (product code HHI), Class II - Special Controls.

Submitted by Gyrus Acmi (Southborough, US). The FDA issued a Cleared decision on September 29, 2017 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5070 - 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. Standard predicate reliance. 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 - K171440

510(k) Number K171440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2017
Decision Date September 29, 2017
Days to Decision 136 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
25d faster than avg
Panel avg: 161d · This submission: 136d
Pathway characteristics
Modification to existing cleared device.

HHI Device Classification - Class 2, Special Controls

Product Code HHI System, Abortion, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5070
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 - HHI System, Abortion, Vacuum

All 23
Devices cleared under the same product code (HHI) and FDA review panel - the closest regulatory comparables to K171440.
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
K030935 · Acmi Corporation · Jun 2003
CYTOPREP
K983181 · Cytoprep Inc. Est. · Nov 1998
MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER
K931205 · Baxter Healthcare Corp · Mar 1994
CYTOSMEAR BRUSH
K904160 · Brooke Intl. · Nov 1990
CANNULA, SUCTION UTERINE
K900641 · Williams Specialty Products, Inc. · Mar 1990
SWIVEL ADAPTER
K900642 · Williams Specialty Products, Inc. · Mar 1990
K171440 · Berkeley VC-10 Vacuum Curettage System
Download PDF FDA Summary Gyrus Acmi