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510(k) K780666

DAYSTAR SELECTRA & SELECTRA/ORBITER by Castle Co. — Product Code FSY

K780666 is an FDA 510(k) premarket notification submitted by Castle Co. for the device "DAYSTAR SELECTRA & SELECTRA/ORBITER". The FDA issued a decision of Substantially Equivalent on April 27, 1978. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Castle Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1978
Date Received
March 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Castle Co.

  • K870975 — MODIFIED CASTLE POWERCLAVE (April 17, 1987)
  • K860263 — CASTLE 7538 FLOOR LOADING WASHER (March 5, 1986)
  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
  • K834048 — BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO (April 4, 1984)
  • K833074 — CASTLE TEC-TEST S.M.A.R.T. PACK (November 7, 1983)
  • K831595 — CASTLE MODEL 3341 & 3441 & 4141 GAS AER (June 15, 1983)
  • K792660 — 1500 EO EXHAUST HOOD (January 29, 1980)
  • K792649 — UNISPORE-BIOLOGICAL INDICATORS (January 29, 1980)
  • K790677 — EO EVACUATING SYSTEM I (May 7, 1979)
  • K781887 — 9100 DAYSTAR AND 9110 ORBITER PACKAGE (December 12, 1978)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)

FDA data resources