Home / 510(k) Clearances / K843498

510(k) K843498

BIPOLAR SUCTION ELECTRODE by Eder Instrument Co, Inc. — Product Code GET

K843498 is an FDA 510(k) premarket notification submitted by Eder Instrument Co, Inc. for the device "BIPOLAR SUCTION ELECTRODE". The FDA issued a decision of Substantially Equivalent on December 14, 1984. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Eder Instrument Co, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1984
Date Received
September 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Eder Instrument Co, Inc.

  • K843497 — SURGICAL KNIVES & PROBES (October 31, 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 GET

  • K960473 — AESCULAP POWER SYSTEM HANDPIECE (March 7, 1996)
  • K955174 — SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (January 22, 1996)
  • K942987 — NUCLEOTOME L KIT (October 30, 1995)
  • K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (October 18, 1995)
  • K953433 — MIDAS REX TELESCOPING SYSTEM (September 15, 1995)
  • K953432 — ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (September 14, 1995)
  • K952463 — GS & GS20 SURGICAL TOOL SYSTEM (July 17, 1995)
  • K952300 — MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (May 26, 1995)
  • K914753 — AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP (June 11, 1992)
  • K910071 — PORTA GAS COMPRESSED GAS CYLINDER CART (March 22, 1991)

FDA data resources