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510(k) K904156

ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS by Origin Medsystems, Inc. — Product Code LZV

K904156 is an FDA 510(k) premarket notification submitted by Origin Medsystems, Inc. for the device "ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS". The FDA issued a decision of Substantially Equivalent on November 27, 1990. The device falls under product code LZV (System, Cement Removal Extraction), a Class II device regulated under 21 CFR 888.4580. Origin Medsystems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1990
Date Received
September 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Cement Removal Extraction
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

Other clearances by Origin Medsystems, Inc.

  • K992353 — BLUNT TIP TROCAR PORT (July 30, 1999)
  • K981700 — VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM (May 29, 1998)
  • K972685 — ORIGIN LIGATOR DEVICE (October 1, 1997)
  • K970611 — ORIGIN CARDIAC STABLIZER OCCLUDER (August 19, 1997)
  • K965121 — CANNULA (March 20, 1997)
  • K964171 — VASOVIEW BALLOON DISSECTION SYSTEM (February 14, 1997)
  • K962104 — AIRLIFT BALLOON RETRACTON SYSTEM (September 11, 1996)
  • K962005 — EXTRAHAND BALLOON RETRACTOR (August 12, 1996)
  • K960936 — RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] (July 24, 1996)
  • K960637 — 5MM ENDOSCOPE (June 14, 1996)

Other clearances for product code LZV

  • K021502 — OSCAR, MODEL OE3000 (June 6, 2002)
  • K961101 — STRYKER CEMENT REMOVAL SYSTEM (July 15, 1996)
  • K930629 — ACRYL-X II SYSTEM (January 21, 1994)
  • K904180 — PROSTHETIC CEMENT REMOVER (November 20, 1990)
  • K891472 — IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR (May 2, 1989)
  • K890285 — PROSTHETIC CEMENT REMOVER (April 19, 1989)

FDA data resources