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510(k) K885066

HEMATOME SYSTEM by Surgical Dynamics, Inc. — Product Code GET

K885066 is an FDA 510(k) premarket notification submitted by Surgical Dynamics, Inc. for the device "HEMATOME SYSTEM". The FDA issued a decision of Substantially Equivalent on May 1, 1989. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Surgical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1989
Date Received
December 6, 1988
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 Surgical Dynamics, Inc.

  • K960046 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE (April 2, 1996)
  • K942987 — NUCLEOTOME L KIT (October 30, 1995)
  • K954193 — SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET (October 23, 1995)
  • K950495 — SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 (May 9, 1995)
  • K931109 — NUCLEOTOME E KIT (March 29, 1994)
  • K921950 — SURGICAL DYNAMICS DISCOGRAPHY SYSTEM (June 7, 1993)
  • K923525 — NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR (February 9, 1993)
  • K913145 — NUCLEOTOME TISSUE ASPIRATOR/CUTTER (December 19, 1991)
  • K914282 — NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER (December 19, 1991)
  • K902778 — SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER (October 30, 1990)

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