510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980976Substantially Equivalent

Ameda Disposable Vacuum Assist Cup with Fluid Retention Trap

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

K980976 is the FDA 510(k) clearance record for AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP, a class II device, cleared for Hollister, Inc. on under FDA product code HDB (Extractor, Vacuum, Fetal). FDA records list 85 510(k) clearances for Hollister, Inc., from to . As of , FDA records show no recalls naming K980976.

Clearance record

Decision date
Received
(158 days to decision)
Product code
HDB Extractor, Vacuum, Fetal
Regulation
21 CFR 884.4340
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hollister, Inc. 2000 Hollister Dr., Libertyville IL
510(k) summary
Summary
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