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510(k) K896622

VISITEC VITRECTOMY UNIT by Visitec Co. — Product Code HKP

K896622 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "VISITEC VITRECTOMY UNIT". The FDA issued a decision of Substantially Equivalent on April 4, 1990. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered), a Class II device regulated under 21 CFR 886.4150. Visitec Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1990
Date Received
November 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Visitec Co.

  • K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (October 12, 1995)
  • K945114 — VISITEC SCLERAL PLUG (February 23, 1995)
  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K942234 — VISITEC PRECISE-POINT (July 12, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K940210 — VISITEC EYE PAD (March 7, 1994)
  • K933872 — VISI-SPEAR EYE SPONGE (December 27, 1993)
  • K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS (November 4, 1992)
  • K922530 — VISITEC MICROSURGICAL SUTURE (October 20, 1992)

Other clearances for product code HKP

  • K952558 — AARON VAC 2 (March 19, 1997)
  • K950056 — THE GRIESHABER AXIAL CUTTER (May 5, 1995)
  • K950287 — UNIVIT PROBE (April 10, 1995)
  • K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR (April 17, 1989)
  • K832074 — CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (August 1, 1983)
  • K822599 — KEATES I/A SYSTEM FRIGITRONICS 4000 (October 6, 1982)
  • K813273 — EMERGENCY POWER PAC (EMPAC) (December 31, 1981)
  • K810152 — X-VEE (March 17, 1981)
  • K801231 — EYE-VAC (July 21, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)

FDA data resources