BERKELEY V-10 VACUUM CURETTAGE SYSTEM— 510(k) K030935

Name: FDA 510(k) clearance K030935
Creator: U.S. Food and Drug Administration
Published: 2003-06-23

Substantially Equivalent

Acmi Corporation

FDA 510(k) clearance K030935 for BERKELEY V-10 VACUUM CURETTAGE SYSTEM, Substantially Equivalent on 2003-06-23. Applicant: Acmi Corporation. Device class: 2.

Clearance details

Applicant: Acmi Corporation
Product code: Code HHI
Device class: Class 2
Regulation: 21 CFR 884.5070
Advisory panel: Obstetrics/Gynecology
Date received: 2003-03-25
Decision date: 2003-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

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K171440 — Berkeley VC-10 Vacuum Curettage System2017-09-29
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K051593 — UROPASS URETERAL ACCESS SHEATH, MODEL 612242005-09-02
K052044 — ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL2005-08-16

Recalls naming K030935

K-number listed on FDA's recall record

Z-0159-2020 — Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/packClass II·Ongoing·Olympus Corporation of the Americas·20190912

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030935.

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