510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901954Substantially Equivalent

Ameda/egnell Dolphin Umbilical Cord Severing Devic

Hollister, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901954 is the FDA 510(k) clearance record for AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC, a class II device, cleared for Hollister, Inc. on under FDA product code HFW (Clamp, Umbilical). FDA records list 85 510(k) clearances for Hollister, Inc., from to . As of , FDA records show no recalls naming K901954.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HFW Clamp, Umbilical
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hollister, Inc. C/O Burdit,Radzius,Chartered, Chicago IL
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HFW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260