510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963223Substantially Equivalent

Ez-Circ

Phyllis Adams, Rn, Npc, Msn, Marlton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963223 is the FDA 510(k) clearance record for EZ-CIRC, a class II device, cleared for Phyllis Adams, Rn, Npc, Msn on under FDA product code HFW (Clamp, Umbilical). FDA records list one 510(k) clearance for Phyllis Adams, Rn, Npc, Msn. As of , FDA records show no recalls naming K963223.

Clearance record

Decision date
Received
(250 days to decision)
Product code
HFW Clamp, Umbilical
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Phyllis Adams, Rn, Npc, Msn 27 Lady Diana Cir., Marlton NJ
510(k) summary
Summary
Third party review
No

Clearances, product code HFW

Trailing 12 months

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

FDA records show no clearances under product code HFW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HFW, 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