Home / 510(k) Clearances / K926225

510(k) K926225

SPONGE COUNTER by American Medical Manufacturer, Inc. — Product Code FWZ

K926225 is an FDA 510(k) premarket notification submitted by American Medical Manufacturer, Inc. for the device "SPONGE COUNTER". The FDA issued a decision of Substantially Equivalent on March 5, 1993. 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
March 5, 1993
Date Received
December 10, 1992
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)
  • K925035 — MIDKIFF GEOSTATIC CLAMP (February 18, 1993)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)
  • K904826 — TKO TELESCOPING LITHOTOMY STIRRUP (October 31, 1990)

FDA data resources