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510(k) K802479

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

K802479 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, 1980. The device falls under product code HXB (Probe), a Class I device regulated under 21 CFR 888.4540. Eder Instrument Co, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Eder Instrument Co, Inc.

  • K843498 — BIPOLAR SUCTION ELECTRODE (December 14, 1984)
  • K843499 — ARTHROSCOPY LEG HOLDER (October 31, 1984)
  • K843497 — SURGICAL KNIVES & PROBES (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)
  • K792100 — GRASPING FORCEP (W/FOUR PRONGS) (November 13, 1979)
  • K791052 — ENDOSCOPIC INSTRUMENT (August 3, 1979)

Other clearances for product code HXB

  • K960539 — DIAO HAND SURGERY SET (July 23, 1996)
  • K943472 — COHORT AVB RETRACTOR SYSTEM (October 20, 1994)
  • K912843 — FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (September 24, 1991)
  • K890227 — SURGICAL PROBE (January 27, 1989)
  • K873652 — HOOK PROBE #TM-1376 (November 2, 1987)
  • K873651 — BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 (November 2, 1987)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K841971 — 2.5MM & 4MM PROBE K841969-LABELING (June 19, 1984)
  • K840558 — SHUTT PRECISION PROBES (April 25, 1984)
  • K810294 — LINE CADDY (February 26, 1981)

FDA data resources