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510(k) K884171

#875 DISPOSABLE BIOPOLAR CABLE by Olsen Electrosurgical, Inc. — Product Code HAM

K884171 is an FDA 510(k) premarket notification submitted by Olsen Electrosurgical, Inc. for the device "#875 DISPOSABLE BIOPOLAR CABLE". The FDA issued a decision of Substantially Equivalent on October 24, 1988. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Olsen Electrosurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1988
Date Received
September 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Olsen Electrosurgical, Inc.

  • K922154 — INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION (April 21, 1994)
  • K912611 — OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE (April 15, 1992)
  • K913108 — TEFLON COATED ELECTRODES/ELECTRODES HANDLES (December 23, 1991)
  • K912612 — SMOKE/ODOR EVACUATOR #757 (November 1, 1991)
  • K885200 — 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE (January 13, 1989)
  • K885199 — #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES (January 13, 1989)
  • K884172 — MODIFIED OLSEN #770 DISPOSABLE HOLSTER (October 24, 1988)
  • K884173 — #920 DISPOSABLE TUR CABLE (October 24, 1988)
  • K884175 — #820/821 BIPOLAR FORCEPS (October 24, 1988)
  • K884174 — MODIFIED OLSEN 755/756 SWITCHPENS (October 24, 1988)

Other clearances for product code HAM

  • K153472 — Quiver Laparoscopic Extendable (June 23, 2016)
  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K913300 — LAPAROSTAT(TM) (April 2, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K911353 — EMC MODEL NO. STATOME 900 (June 24, 1991)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)

FDA data resources