510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900472Substantially Equivalent

Skytron Model 860 and 800 Comp. Surgita Neuro Equi

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

K900472 is the FDA 510(k) clearance record for SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI, a class I device, cleared for Skytron, Div. the Kmw Group, Inc. on under FDA product code HBN (Chair, Neurosurgical). FDA records list 19 510(k) clearances for Skytron, LLC, from to . As of , FDA records show no recalls naming K900472.

Clearance record

Decision date
Received
(216 days to decision)
Product code
HBN Chair, Neurosurgical
Regulation
21 CFR 882.4125
Device class
Class I
Review panel
Neurology
Applicant
Skytron, Div. the Kmw Group, Inc. 5000 36th St., SE, Grand Rapids MI
Third party review
No

Clearances, product code HBN

Trailing 12 months

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

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