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510(k) K811311

SKYTRON ELITE SURGICAL TABLES by Skytron, Div. the Kmw Group, Inc. — Product Code GBC

K811311 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON ELITE SURGICAL TABLES". The FDA issued a decision of Substantially Equivalent on June 2, 1981. The device falls under product code GBC (Lamp, Surgical, Incandescent), a Class II device regulated under 21 CFR 878.4580. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1981
Date Received
May 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical, Incandescent
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Skytron, Div. the Kmw Group, Inc.

  • K071698 — AURORA LED SERIES SURGICAL LIGHTS (July 6, 2007)
  • K021585 — STELLAR SERIES SURGICAL LIGHTS WITH HERMES (November 13, 2002)
  • K002463 — STELLAR (November 8, 2000)
  • K992090 — MILLENNIUM GOLD (September 8, 1999)
  • K950192 — SKYTRON SKYBOOM SERIES (April 3, 1995)
  • K940616 — SKYTRON ELITE 3500 TABLE (June 13, 1994)
  • K933564 — SKYTRON EXAM LIGHT (February 10, 1994)
  • K926045 — SKYTRON LIFE ISLAND 21 (July 27, 1993)
  • K915285 — SKYTRON INFINITY SERIES SURGICAL LIGHTS (February 20, 1992)
  • K900472 — SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI (September 4, 1990)

Other clearances for product code GBC

  • K896961 — HALUX EXLITE MINOR SURGERY LIGHT (February 22, 1990)
  • K830610 — FLAT SUCTION DRAIN (March 29, 1983)
  • K810207 — MINOR SURGERY LIGHT (February 13, 1981)

FDA data resources