510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041579Substantially Equivalent

Medela Single Use Silc Cup, Model 077.0791

Medela AG, Baar Zug, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041579 is the FDA 510(k) clearance record for MEDELA SINGLE USE SILC CUP, MODEL 077.0791, a class II device, cleared for Medela AG on under FDA product code HDB (Extractor, Vacuum, Fetal). FDA records list 56 510(k) clearances for Medela AG, from to . As of , FDA records show no recalls naming K041579.

Clearance record

Decision date
Received
(311 days to decision)
Product code
HDB Extractor, Vacuum, Fetal
Regulation
21 CFR 884.4340
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medela AG Laettichstrasse 4b, Baar Zug, CH
510(k) summary
Summary PDF
Third party review
Yes

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