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510(k) K894336

SURGICAL DYNAMICS DISCOGRAPHY SYSTEM by Surgical Dynamics, Inc.

K894336 is an FDA 510(k) premarket notification submitted by Surgical Dynamics, Inc. for the device "SURGICAL DYNAMICS DISCOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 4, 1989. Surgical Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
August 4, 1989
Date Received
July 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)

FDA data resources