510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K850168Substantially Equivalent

Stille Scandia Operating Tables Rc 3000,1100

Stille-Werner (USA), Inc., Ronkonkoma NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850168 is the FDA 510(k) clearance record for STILLE SCANDIA OPERATING TABLES RC 3000,1100, a class I device, cleared for Stille-Werner (Usa), Inc. on under FDA product code GDC (Table, Operating-Room, Electrical). FDA records list one 510(k) clearance for Stille-Werner (Usa), Inc. As of , FDA records show no recalls naming K850168.

Clearance record

Decision date
Received
(71 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
Stille-Werner (Usa), Inc. 200 Thirteenth Ave., Ronkonkoma NY
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