510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150660Substantially Equivalent

Alcyone MEMS Cannula (AMC) System

Alcyone Lifesciences, Inc., Lowell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150660 is the FDA 510(k) clearance record for Alcyone MEMS Cannula (AMC) System, a class I device, cleared for Alcyone Lifesciences, Inc. on under FDA product code HCD (Cannula, Ventricular). FDA records list 2 510(k) clearances for Alcyone Lifesciences, Inc., from to . As of , FDA records show no recalls naming K150660.

Clearance record

Decision date
Received
(34 days to decision)
Product code
HCD Cannula, Ventricular
Regulation
21 CFR 882.4060
Device class
Class I
Review panel
Neurology
Applicant
Alcyone Lifesciences, Inc. 130 John St., Boot Canal Mill Bldg., C-2, Lowell MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HCD

Trailing 12 months

FDA records hold no clearances under product code HCD in the trailing twelve months.

FDA records show no clearances under product code HCD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260