Home / 510(k) Clearances / K884928

510(k) K884928

FREE ARM(TM) by Faro Medical Technologies, Inc. — Product Code FWZ

K884928 is an FDA 510(k) premarket notification submitted by Faro Medical Technologies, Inc. for the device "FREE ARM(TM)". The FDA issued a decision of Substantially Equivalent on December 15, 1988. The device falls under product code FWZ (Operating Room Accessories Table Tray), a Class I device regulated under 21 CFR 878.4950.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1988
Date Received
November 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Operating Room Accessories Table Tray
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

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 guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances for product code FWZ

  • K960019 — RETRACTOR ARM CLAMP (February 9, 1996)
  • K945415 — 'LIL MAC ACCESSORY CLAMP(TM) (November 22, 1994)
  • K944779 — CARBON LIGHTS HAND SURGERY TABLE (October 14, 1994)
  • K935381 — KAPS POSITIONING ARM (April 15, 1994)
  • K931037 — WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) (July 30, 1993)
  • K926225 — SPONGE COUNTER (March 5, 1993)
  • K925035 — MIDKIFF GEOSTATIC CLAMP (February 18, 1993)
  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)

FDA data resources