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510(k) K911522

ARTHROBOT(TM) WRIST HOLDER ACCESSORY by Andronic Devices, Ltd. — Product Code JEA

K911522 is an FDA 510(k) premarket notification submitted by Andronic Devices, Ltd. for the device "ARTHROBOT(TM) WRIST HOLDER ACCESSORY". The FDA issued a decision of Substantially Equivalent on April 29, 1991. The device falls under product code JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. Andronic Devices, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1991
Date Received
April 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Surgical With Orthopedic Accessories, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

Other clearances by Andronic Devices, Ltd.

  • K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR (November 21, 1994)
  • K934928 — INSITE FILTER & TUBING SET (May 26, 1994)
  • K934926 — INSITE MODEL 20 & MODEL 15 INSUFFLATORS (May 26, 1994)
  • K935381 — KAPS POSITIONING ARM (April 15, 1994)
  • K934124 — AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM (April 13, 1994)
  • K936308 — ENDEX ENDOSCOPIC POSITIONING SYSTEM (March 31, 1994)
  • K932253 — ARTHROBOT BI-FOLD DRAPE (February 3, 1994)
  • K922626 — ADEPT INSTRUMENT POSITIONING ACCESSORY (October 19, 1992)
  • K922625 — ADEPT ENDOSCOPIC POSITIONER (October 19, 1992)
  • K911520 — ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE (August 2, 1991)

Other clearances for product code JEA

  • K953071 — STRYKER COMMAND2 OFFICE CONSOLE (August 8, 1995)
  • K924094 — MEND APC (March 30, 1993)
  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K900290 — SKYTRON MODEL 1100 AND MODEL 142 (February 20, 1990)
  • K894789 — DMI 250 SERIES POWER SURGERY TABLE (August 29, 1989)
  • K881060 — OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) (March 25, 1988)
  • K874762 — ARTHROTRACT UPPER LIMB TRACTION ACCESSORY (December 10, 1987)
  • K873080 — ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY (November 25, 1987)
  • K873079 — ARTHROBOT 100 UPPER LIMB POSITIONER (November 25, 1987)

FDA data resources