510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853480Substantially Equivalent

Skytron Elite 6000 & 6001 Surgical Tables

Skytron, LLC, Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853480 is the FDA 510(k) clearance record for SKYTRON ELITE 6000 & 6001 SURGICAL TABLES, a class I device, cleared for Skytron, Div. the Kmw Group, Inc. on under FDA product code GDC (Table, Operating-Room, Electrical). FDA records list 19 510(k) clearances for Skytron, LLC, from to . As of , FDA records show no recalls naming K853480.

Clearance record

Decision date
Received
(23 days to decision)
Product code
GDC Table, Operating-Room, Electrical
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Skytron, Div. the Kmw Group, Inc. 5000 36th St., SE, Grand Rapids MI
Third party review
No

Clearances, product code GDC

Trailing 12 months

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

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