510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821563Substantially Equivalent

Argyle Vac-U-Care 100Cc Suction Reserv

Sherwood Medical Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821563 is the FDA 510(k) clearance record for ARGYLE VAC-U-CARE 100CC SUCTION RESERV, a class I device, cleared for Sherwood Medical Co. on under FDA product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K821563.

Clearance record

Decision date
Received
(27 days to decision)
Product code
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Regulation
21 CFR 878.4680
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sherwood Medical Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GCY

Trailing 12 months

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

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