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510(k) K821933

OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. by Polamedco, Inc. — Product Code FWZ

K821933 is an FDA 510(k) premarket notification submitted by Polamedco, Inc. for the device "OMNISURG SIDE MOUNTING CLAMP & RAIL EXT.". The FDA issued a decision of Substantially Equivalent on July 8, 1982. The device falls under product code FWZ (Operating Room Accessories Table Tray), a Class I device regulated under 21 CFR 878.4950. Polamedco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1982
Date Received
June 29, 1982
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 by Polamedco, Inc.

  • K983000 — CRICOTHYROTOMY TUBE (October 27, 1999)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K953793 — INTROSCOPE (November 29, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATION (February 13, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)
  • K920900 — POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES (March 18, 1992)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K900457 — CUFFED LINDER NASOTRACHEAL AIRWAY (April 16, 1990)
  • K894516 — VISOSHIELD(TM), SURGICAL EYE PROTECTOR (September 12, 1989)

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)
  • K905564 — PREP AND OPERATING STAND (February 21, 1991)
  • K905565 — LATERAL BUTTRESS SUPPORT (February 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)

FDA data resources