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510(k) K843497

SURGICAL KNIVES & PROBES by Eder Instrument Co, Inc. — Product Code EMF

K843497 is an FDA 510(k) premarket notification submitted by Eder Instrument Co, Inc. for the device "SURGICAL KNIVES & PROBES". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. Eder Instrument Co, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
September 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Eder Instrument Co, Inc.

  • K843498 — BIPOLAR SUCTION ELECTRODE (December 14, 1984)
  • K843499 — ARTHROSCOPY LEG HOLDER (October 31, 1984)
  • K831255 — LARYNGOSCOPE ATTACHMENT PH2000 (September 12, 1983)
  • K831240 — LASER BRONCHOSCOPE (July 26, 1983)
  • K831241 — LASER LAPARAXOPE (June 10, 1983)
  • K822959 — ENDOSCOPIC VIDEOSYSTEM (October 22, 1982)
  • K802479 — SURGICAL KNIVES & PROBES (October 31, 1980)
  • K792100 — GRASPING FORCEP (W/FOUR PRONGS) (November 13, 1979)
  • K791052 — ENDOSCOPIC INSTRUMENT (August 3, 1979)

Other clearances for product code EMF

  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (March 13, 2008)
  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)
  • K890217 — MICROSURGICAL KNIVES (January 27, 1989)
  • K890215 — MICROSURGICAL SCARIFIER (January 27, 1989)
  • K890214 — MICROSURGERY RAZOR BLADE HOLDER (January 27, 1989)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K863752 — VALTRAC (BAR) REMOVER DEVICE (October 24, 1986)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K861947 — SURGICAL KNIFE (June 6, 1986)
  • K854891 — KNIFE (May 2, 1986)

FDA data resources