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510(k) K890595

MENTOR ANTERIOR SEGMENT VITRECTOR by Mentor O & O, Inc. — Product Code HKP

K890595 is an FDA 510(k) premarket notification submitted by Mentor O & O, Inc. for the device "MENTOR ANTERIOR SEGMENT VITRECTOR". The FDA issued a decision of Substantially Equivalent on April 17, 1989. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered), a Class II device regulated under 21 CFR 886.4150. Mentor O & O, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1989
Date Received
February 6, 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 Mentor O & O, Inc.

  • K955245 — MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM (February 12, 1996)
  • K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A (February 16, 1994)
  • K912904 — MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM (June 11, 1992)
  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K910637 — MENTOR(R) SUR-E-TROL(R) (May 13, 1991)
  • K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 (May 2, 1991)
  • K903878 — MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT (November 5, 1990)
  • K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE (September 11, 1989)
  • K890622 — SURG-E-TROL SYSTEM I AND SYSTEM II (May 4, 1989)
  • K881001 — MENTOR WET-FIELD*II COAGULATOR (May 13, 1988)

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)
  • K896622 — VISITEC VITRECTOMY UNIT (April 4, 1990)
  • 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