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510(k) K953433

MIDAS REX TELESCOPING SYSTEM by Midas Rex Pneumatic Tools, Inc. — Product Code GET

K953433 is an FDA 510(k) premarket notification submitted by Midas Rex Pneumatic Tools, Inc. for the device "MIDAS REX TELESCOPING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Midas Rex Pneumatic Tools, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
July 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Midas Rex Pneumatic Tools, Inc.

  • K972289 — MIDAS REX MOTOR (September 12, 1997)
  • K970965 — MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) (April 9, 1997)
  • K962483 — MIDAS REX III MOTOR (November 19, 1996)
  • K953434 — MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) (May 16, 1996)
  • K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (October 18, 1995)
  • K953432 — ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (September 14, 1995)
  • K952463 — GS & GS20 SURGICAL TOOL SYSTEM (July 17, 1995)
  • K952300 — MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (May 26, 1995)
  • K900388 — MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES (May 7, 1990)
  • K854462 — MIDAS REX SURGICAL RUBBER DAM (November 22, 1985)

Other clearances for product code GET

  • K960473 — AESCULAP POWER SYSTEM HANDPIECE (March 7, 1996)
  • K955174 — SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (January 22, 1996)
  • K942987 — NUCLEOTOME L KIT (October 30, 1995)
  • K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (October 18, 1995)
  • K953432 — ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (September 14, 1995)
  • K952463 — GS & GS20 SURGICAL TOOL SYSTEM (July 17, 1995)
  • K952300 — MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (May 26, 1995)
  • K914753 — AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP (June 11, 1992)
  • K910071 — PORTA GAS COMPRESSED GAS CYLINDER CART (March 22, 1991)
  • K904578 — MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP (October 30, 1990)

FDA data resources