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510(k) K863091

BICORD BY QMED by Qmed, Inc. — Product Code HAM

K863091 is an FDA 510(k) premarket notification submitted by Qmed, Inc. for the device "BICORD BY QMED". The FDA issued a decision of Substantially Equivalent on August 29, 1986. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Qmed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1986
Date Received
August 13, 1986
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 Qmed, Inc.

  • K972991 — MONITOR ONE NDX (December 3, 1998)
  • K932109 — PROFILOMAT (December 3, 1993)
  • K921476 — INTERP-1000 (October 21, 1992)
  • K897121 — QEKG ELECTROCARDIOGRAPH (April 30, 1990)
  • K873591 — A.R.M. (ASPEN RETURN MONITOR) (September 30, 1987)
  • K862377 — QMED SELF ADHERING ELECTRODE (September 26, 1986)
  • K861437 — QMED SYSTEM 2150 (May 20, 1986)
  • K843559 — KLEENIT BY QMED (October 24, 1984)
  • K841172 — MONITOR ONE (July 27, 1984)
  • K840465 — Q-MED ELECTRODE (June 19, 1984)

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