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510(k) K912237

STRYKER ECLIPSE WARMING STRETCHER by Stryker Medical — Product Code DWI

K912237 is an FDA 510(k) premarket notification submitted by Stryker Medical for the device "STRYKER ECLIPSE WARMING STRETCHER". The FDA issued a decision of Substantially Equivalent on July 30, 1991. The device falls under product code DWI (Saw, Electrically Powered), a Class I device regulated under 21 CFR 878.4820. Stryker Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1991
Date Received
May 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saw, Electrically Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Stryker Medical

  • K222818 — Xpedition ™ Powered Stair Chair (625700000000) (January 24, 2023)
  • K180834 — Altrix Precision Temperature Management System (August 10, 2018)
  • K171149 — Altrix Temperature Management Wraps (July 18, 2017)
  • K152266 — Altrix Precision Temperature Management System (December 2, 2016)
  • K113598 — POWER-LOAD COT FASTENER SYSTEM (December 20, 2011)
  • K946149 — STRYKER AGILITY INTENSIVE CARE BED (March 14, 1995)
  • K943864 — STRYKER 8000 SURGERY STRETCHER (August 25, 1994)
  • K935949 — STRYKER 5000 (June 17, 1994)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K940068 — STRYKER OPERATING ROOM TABLE (May 5, 1994)

Other clearances for product code DWI

  • K801914 — TEMP STERNUM SAW (October 23, 1980)

FDA data resources