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510(k) K780293

ELECTROSURGICAL UNIT by Ritter Co. — Product Code HAM

K780293 is an FDA 510(k) premarket notification submitted by Ritter Co. for the device "ELECTROSURGICAL UNIT". The FDA issued a decision of Substantially Equivalent on March 14, 1978. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Ritter Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1978
Date Received
February 21, 1978
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 Ritter Co.

  • K831245 — TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO (October 19, 1983)
  • K832171 — SELF CHECK DIGITAL BLOOD PRESS. MONITOR (October 4, 1983)
  • K831976 — POWER OPTIC (August 12, 1983)
  • K823180 — SA-21 DENTAL UNIT (November 22, 1982)
  • K800084 — RITTER MODEL J DENTAL CHAIR (January 29, 1980)
  • K781101 — ELECTROSURGICAL UNIT 75 (July 17, 1978)
  • K772300 — DENTAL CHAIR, VANGUARD (January 3, 1978)
  • K760929 — ACCUTORQ II (November 19, 1976)
  • K760707 — RITTER STARLIGHT DENTAL OPERATING LIGHT (October 5, 1976)

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