510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970352Substantially Equivalent

Smartvac Smoke Evacuation System

Isomedix Operations Inc, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970352 is the FDA 510(k) clearance record for SMARTVAC SMOKE EVACUATION SYSTEM, a class II device, cleared for Isomedix Operations, Inc. on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list 2 510(k) clearances for Isomedix Operations, Inc., from to . As of , FDA records show no recalls naming K970352.

Clearance record

Decision date
Received
(278 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Isomedix Operations, Inc. 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code FYD

Trailing 12 months

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

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