510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K041084Substantially Equivalent

Clip-on Spacer 20%; 40%; 50%

Serono, Inc., Rockland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041084 is the FDA 510(k) clearance record for CLIP-ON SPACER 20%; 40%; 50%, a class II device, cleared for Serono, Inc. on under FDA product code FMF (Syringe, Piston). FDA records list one 510(k) clearance for Serono, Inc. As of , FDA records show no recalls naming K041084.

Clearance record

Decision date
Received
(80 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Serono, Inc. One Technology Pl., Rockland MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260