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510(k) K942987

NUCLEOTOME L KIT by Surgical Dynamics, Inc. — Product Code GET

K942987 is an FDA 510(k) premarket notification submitted by Surgical Dynamics, Inc. for the device "NUCLEOTOME L KIT". The FDA issued a decision of Substantially Equivalent on October 30, 1995. 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
October 30, 1995
Date Received
June 20, 1994
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)
  • 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)
  • K914282 — NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER (December 19, 1991)
  • K913145 — NUCLEOTOME TISSUE ASPIRATOR/CUTTER (December 19, 1991)
  • K902778 — SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER (October 30, 1990)
  • K894336 — SURGICAL DYNAMICS DISCOGRAPHY SYSTEM (August 4, 1989)

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)
  • 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)
  • K904578 — MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP (October 30, 1990)

FDA data resources