510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911522Substantially Equivalent

Arthrobot(tm) Wrist Holder Accessory

Andronic Devices, Ltd., Richmond,B.C. V6v-2j2, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911522 is the FDA 510(k) clearance record for ARTHROBOT(TM) WRIST HOLDER ACCESSORY, a class I device, cleared for Andronic Devices, Ltd. on under FDA product code JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered). FDA records list 16 510(k) clearances for Andronic Devices, Ltd., from to . As of , FDA records show no recalls naming K911522.

Clearance record

Decision date
Received
(25 days to decision)
Product code
JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Andronic Devices, Ltd. 13120 Vanier Pl., Richmond,B.C. V6v-2j2, CA
Third party review
No

Clearances, product code JEA

Trailing 12 months

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

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