510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860446Substantially Equivalent

C Arm Surgical Table

Medi-Mech, Inc., The Dalles OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860446 is the FDA 510(k) clearance record for C ARM SURGICAL TABLE, a class I device, cleared for Medi-Mech, Inc. on under FDA product code FWZ (Operating Room Accessories Table Tray). FDA's definition for product code FWZ reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list one 510(k) clearance for Medi-Mech, Inc. As of , FDA records show no recalls naming K860446.

Clearance record

Decision date
Received
(34 days to decision)
Product code
FWZ Operating Room Accessories Table Tray
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Medi-Mech, Inc. P.O. Box 976, The Dalles OR
Third party review
No

Clearances, product code FWZ

Trailing 12 months

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

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