510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K901557Substantially Equivalent

Umbilical Cord Clamp and Cutter

Microtek-Heritage, Inc., Tucker GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901557 is the FDA 510(k) clearance record for UMBILICAL CORD CLAMP AND CUTTER, a class II device, cleared for Microtek-Heritage, Inc. on under FDA product code HFW (Clamp, Umbilical). FDA records list one 510(k) clearance for Microtek-Heritage, Inc. As of , FDA records show no recalls naming K901557.

Clearance record

Decision date
Received
(42 days to decision)
Product code
HFW Clamp, Umbilical
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Microtek-Heritage, Inc. P.O. Box 1147, Tucker GA
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