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510(k) K945861

BERGEN 710 ESU by Bergen Mfg. — Product Code HAM

K945861 is an FDA 510(k) premarket notification submitted by Bergen Mfg. for the device "BERGEN 710 ESU". The FDA issued a decision of Substantially Equivalent on March 1, 1995. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Bergen Mfg. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
December 1, 1994
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 Bergen Mfg.

  • K972299 — BERGEN MODEL 500 ELECTROSURGERY GENERATOR (August 27, 1997)
  • K964736 — BERGEN 610 BIPOLAR COAGULATOR (February 27, 1997)
  • K863701 — MODEL 709 BIPOLAR MICRO COAGULATOR (October 14, 1986)

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)
  • 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)
  • K894663 — BEAMER ONE (September 15, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)

FDA data resources