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510(k) K832186

HALL DRILL/REAMER by Amsco Co. — Product Code GET

K832186 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "HALL DRILL/REAMER". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Amsco Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
July 6, 1983
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 Amsco Co.

  • K912471 — EAGLE 3000 SDS (June 26, 1992)
  • K854922 — AMSCO POLARIS SL (January 24, 1986)
  • K833187 — HALL OSTEON (October 31, 1983)
  • K832945 — EAGLE 2000 STERILIZER SERIES GAS/AERA (October 19, 1983)
  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K832187 — HALL OSCILLATOR (August 12, 1983)
  • K832188 — HALL RECIPROCATOR (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K823360 — SURGICAL LIGHT (December 3, 1982)
  • K811242 — DISPOSABLE STERILIZATION WRAP (May 21, 1981)

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)
  • K953433 — MIDAS REX TELESCOPING SYSTEM (September 15, 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)

FDA data resources