510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043614Substantially Equivalent

Vaculink, Model Vcl 3000

Medevco, Inc., Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043614 is the FDA 510(k) clearance record for VACULINK, MODEL VCL 3000, a class II device, cleared for Medevco, Inc. on under FDA product code HDB (Extractor, Vacuum, Fetal). FDA records list one 510(k) clearance for Medevco, Inc. As of , FDA records show no recalls naming K043614.

Clearance record

Decision date
Received
(105 days to decision)
Product code
HDB Extractor, Vacuum, Fetal
Regulation
21 CFR 884.4340
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medevco, Inc. 2300 Mcdermott Rd., Plano TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HDB

Trailing 12 months

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

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