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510(k) K810152

X-VEE by Temporaty Surgical Systems — Product Code HKP

K810152 is an FDA 510(k) premarket notification submitted by Temporaty Surgical Systems for the device "X-VEE". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered), a Class II device regulated under 21 CFR 886.4150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1981
Date Received
January 21, 1981
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 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)
  • K801231 — EYE-VAC (July 21, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)

FDA data resources