510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850634Substantially Equivalent

Surgidyne Surgiflo C.w.s. Drain Products

Surgidyne, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850634 is the FDA 510(k) clearance record for SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS, a class I device, cleared for Surgidyne, Inc. on under FDA product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered). FDA records list 6 510(k) clearances for Surgidyne, Inc., from to . As of , FDA records show no recalls naming K850634.

Clearance record

Decision date
Received
(129 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
Surgidyne, Inc. 6975 Washington Ave., Minneapolis MN
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