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510(k) K883578

S 21 INSTRUMENT STAND by Carl Zeiss, Inc. — Product Code FSH

K883578 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "S 21 INSTRUMENT STAND". The FDA issued a decision of Substantially Equivalent on September 13, 1988. The device falls under product code FSH (Tray, Surgical, Needle), a Class I device regulated under 21 CFR 878.4800. Carl Zeiss, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1988
Date Received
August 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Needle
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Carl Zeiss, Inc.

  • K013402 — VISULAS 532S (November 14, 2001)
  • K003885 — VISULAS YAG II (February 22, 2001)
  • K993357 — IOLMASTER (March 20, 2000)
  • K983868 — OPMI TWINER SURGICAL MICROSCOPE (January 29, 1999)
  • K965139 — SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM (April 23, 1997)
  • K961380 — CPC PROBE (March 17, 1997)
  • K961171 — HUMPHREY OCT SCANNER (June 21, 1996)
  • K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
  • K952894 — VISULINK 900 ARGON (August 14, 1995)
  • K950985 — ZEISS ENDOLIVE STERO ENDOSCOPE (March 29, 1995)

Other clearances for product code FSH

  • K884876 — S 4 INSTRUMENT STAND (December 15, 1988)
  • K821921 — STAND, SURG. INSTRUMENT & DRESSING (July 30, 1982)
  • K813338 — BIOPSY NEEDLES & TRAYS (January 28, 1982)
  • K813337 — SKINNY CHIBA NEEDLE & TRAY (January 28, 1982)
  • K813335 — PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY (January 8, 1982)
  • K780759 — MODEL 902 STAND (May 19, 1978)
  • K772188 — FSH RIA KIT (125I) (December 22, 1977)

FDA data resources