510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813282Substantially Equivalent

Synevac Vacuum Curettage Systems

Synemed, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813282 is the FDA 510(k) clearance record for SYNEVAC VACUUM CURETTAGE SYSTEMS, a class II device, cleared for Synemed, Inc. on under FDA product code HHI (System, Abortion, Vacuum). FDA records list 8 510(k) clearances for Synemed, Inc., from to . As of , FDA records show no recalls naming K813282.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HHI System, Abortion, Vacuum
Regulation
21 CFR 884.5070
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Synemed, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HHI

Trailing 12 months

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

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