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510(k) K860177

ALLEN UNIVERSAL STIRRUP by Edgewater Medical Equipment Systems — Product Code BWN

K860177 is an FDA 510(k) premarket notification submitted by Edgewater Medical Equipment Systems for the device "ALLEN UNIVERSAL STIRRUP". The FDA issued a decision of Substantially Equivalent on February 11, 1986. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Edgewater Medical Equipment Systems has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1986
Date Received
January 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by Edgewater Medical Equipment Systems

  • K873370 — ALLEN MALLEABLE ANESTHESIA SCREEN (September 11, 1987)
  • K872900 — THE PORTABLE ORDERLY (August 21, 1987)

Other clearances for product code BWN

  • K942699 — AIRFRAME SURGICAL DRAPE SUPPORT (July 13, 1994)
  • K935441 — INFINITECH BREATH EZ (February 7, 1994)
  • K925005 — ISI SELF-SUPPORTING ARM (April 29, 1993)
  • K922288 — HOLDER, PEDIATRIC POSITION (February 10, 1993)
  • K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (April 2, 1991)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K884558 — IOP ADJUSTABLE STIRRUP (November 17, 1988)
  • K875291 — SPINAL SURGERY FRAME (January 22, 1988)
  • K873272 — ENDOSCOPY TABLE 1532 ENDOSTAR (September 8, 1987)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)

FDA data resources