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510(k) K801382

DISPOSABLE SURGICAL HEAD SUPPORT by Innovative Surgical Products, Inc. — Product Code FSE

K801382 is an FDA 510(k) premarket notification submitted by Innovative Surgical Products, Inc. for the device "DISPOSABLE SURGICAL HEAD SUPPORT". The FDA issued a decision of Substantially Equivalent on June 26, 1980. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Innovative Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1980
Date Received
June 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Innovative Surgical Products, Inc.

  • K843041 — HESLIN DISPOS. TUBING SET (November 21, 1984)
  • K840695 — PHACOEMULSIFICATION KITS (May 22, 1984)
  • K840693 — DISPOSABLE SCLERAL GLOBE PLUG (May 22, 1984)
  • K840694 — LENS INSERTION GLIDE (May 9, 1984)
  • K841072 — IRRIGATION, ASPIRATION TUBING SETS (March 29, 1984)
  • K832235 — DISPOSABLE VITRECTOMY HANDPIECE (September 29, 1983)
  • K821496 — DISPOSABLE IRRIGA/ASPIR. SYSTEM (June 22, 1982)
  • K820765 — PLEURAL DRAINAGE RESERVOIR (April 15, 1982)
  • K820680 — DISPOSABLE TUBING SETS (April 9, 1982)
  • K802973 — ISPVAC TM (December 19, 1980)

Other clearances for product code FSE

  • K860503 — THE POREX RETRACTOR TABLE (March 13, 1986)
  • K843801 — MASON EQUIPMENT ORGANIZER & ASPEN (October 25, 1984)
  • K840027 — OPERATING ROOM STAND (February 4, 1984)
  • K831042 — CHEMONUCLEOLYSIS TABLE EXTENSION (May 16, 1983)
  • K830339 — IMSI/METRIPOND HAND OPERATING TABLE (April 12, 1983)
  • K822427 — SELF-CONTAINED MOBILE OPHTHAL. OPER. . (September 14, 1982)
  • K821924 — TABLE, OPERATING, FIELD 6530-00-709-8155 (July 13, 1982)
  • K782092 — ARMBOARD CVER, DISPOSABLE (January 10, 1979)
  • K780866 — CHEST ROLLS HOLDER (August 14, 1978)
  • K780868 — CHEST ROLLS (August 14, 1978)

FDA data resources