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510(k) K780852

CLINITEX VIS-X ASPIRATING ACCESSORY by Varian Assoc., Inc. — Product Code HKP

K780852 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "CLINITEX VIS-X ASPIRATING ACCESSORY". The FDA issued a decision of Substantially Equivalent on November 3, 1978. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered), a Class II device regulated under 21 CFR 886.4150. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1978
Date Received
May 22, 1978
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 Varian Assoc., Inc.

  • K000922 — PROTON VISION (May 24, 2000)
  • K992762 — BRACHYVISION 6.0 (March 9, 2000)
  • K992751 — SOMAVISION (February 16, 2000)
  • K992753 — CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM (September 3, 1999)
  • K990085 — MILLENNIUM MLC -120 (February 8, 1999)
  • K980601 — VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE (October 21, 1998)
  • K955844 — APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER (July 26, 1996)
  • K954467 — CADPLAN BT (March 15, 1996)
  • K955774 — VARIS PORTALVISION (March 15, 1996)
  • K943224 — VARIAN MULTILEAF COLLIMATOR (February 2, 1996)

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)
  • 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)

FDA data resources