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510(k) K812234

STORZ/OLYMPUS MICROSCOPE SYSTEM by Storz Instrument Co. — Product Code EPT

K812234 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "STORZ/OLYMPUS MICROSCOPE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 11, 1981. The device falls under product code EPT (Microscope, Surgical), a Class I device regulated under 21 CFR 878.4700. Storz Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1981
Date Received
August 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Surgical
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Storz Instrument Co.

  • K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK (June 1, 1998)
  • K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM (March 23, 1998)
  • K972664 — STORZ MILLENNIUM VISCOUS FLUID SYSTEM (October 10, 1997)
  • K971439 — STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES (June 17, 1997)
  • K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR (February 3, 1997)
  • K960024 — STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE (September 20, 1996)
  • K960061 — STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE (September 18, 1996)
  • K960003 — STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION (August 29, 1996)
  • K962131 — STORZ D4600 AIR EXCHANGE LINE PACK (August 23, 1996)
  • K961874 — STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK (August 6, 1996)

Other clearances for product code EPT

  • K942233 — MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM (July 1, 1994)
  • K931284 — MICRODYNE OFFICE SURGICAL MICROSCOPE (November 18, 1993)
  • K933310 — MICRINS CONTRAST BACKGROUND MATERIAL (August 19, 1993)
  • K903412 — STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR. (September 20, 1990)
  • K883581 — OPMI CS (September 13, 1988)
  • K882269 — STORZ DIAGNOSTIC MICROSCOPE SYSTEM (June 23, 1988)
  • K860811 — ZEISS VOICE CONTROL SYSTEM FOR OPMI'S (April 30, 1986)
  • K844858 — STORZ/URBAN SURGICAL MICROSCOPE SYSTEM (March 25, 1985)
  • K832887 — ELECTRONIC UNIT (October 4, 1983)
  • K823011 — VC III (November 8, 1982)

FDA data resources