Berkeley VC-10 Vacuum Curettage System— 510(k) K171440

Name: FDA 510(k) clearance K171440
Creator: U.S. Food and Drug Administration
Published: 2017-09-29

Substantially Equivalent

Gyrus Acmi

FDA 510(k) clearance K171440 for Berkeley VC-10 Vacuum Curettage System, Substantially Equivalent on 2017-09-29. Applicant: Gyrus Acmi. Device class: 2.

Clearance details

Applicant: Gyrus Acmi
Product code: Code HHI
Device class: Class 2
Regulation: 21 CFR 884.5070
Advisory panel: Obstetrics/Gynecology
Date received: 2017-05-16
Decision date: 2017-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHI

view all

K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM2003-06-23
K983181 — CYTOPREP1998-11-16
K931205 — MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER1994-03-15
K904160 — CYTOSMEAR BRUSH1990-11-02
K900641 — CANNULA, SUCTION UTERINE1990-03-30

Recalls naming K171440

K-number listed on FDA's recall record

Z-0078-2023 — Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.Class II·Ongoing·Olympus Corporation of the Americas·20220916

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171440.

Data sourced from openFDA. This site is unofficial and independent of the FDA.