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510(k) K861147

UCS-2, ULTRASONIC CLEANING SOLUTION by Keymed, Inc. — Product Code FLG

K861147 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "UCS-2, ULTRASONIC CLEANING SOLUTION". The FDA issued a decision of Substantially Equivalent on June 23, 1986. The device falls under product code FLG (Cleaner, Ultrasonic, Medical Instrument), a Class I device regulated under 21 CFR 880.6150. Keymed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1986
Date Received
March 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Ultrasonic, Medical Instrument
Device Class
Class I
Regulation Number
880.6150
Review Panel
HO
Submission Type

Other clearances by Keymed, Inc.

  • K100803 — OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (April 22, 2010)
  • K921179 — OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 (March 29, 1993)
  • K881004 — OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR (May 12, 1988)
  • K861821 — KEYMED FIBERSCOPE AUTO DISINFECTOR (February 12, 1987)
  • K864801 — THE KEYMED HI-LIGHT 250 LIGHT SOURCE (December 24, 1986)
  • K862000 — KEYMED FLEXIBLE ESOPHAGEAL DILATORS (August 12, 1986)
  • K860528 — THE KEYMED FIBERSCOPE STERILIZATION CASE (July 15, 1986)
  • K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (June 17, 1986)
  • K851149 — KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (November 26, 1985)
  • K854304 — KEYMED OFFICE COUCH (November 12, 1985)

Other clearances for product code FLG

  • K944950 — KLENZYME (December 20, 1994)
  • K944494 — ALSA-KLENZ (October 19, 1994)
  • K944033 — BILL EVANS-KLENZ (October 7, 1994)
  • K940263 — NPH-KLENZ (May 18, 1994)
  • K941163 — MON-KLENZ (May 18, 1994)
  • K935063 — INSTRU KLENZ (May 9, 1994)
  • K934666 — PDS ULTRACLEAN (April 15, 1994)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K933149 — INSTRUMENT DETERGENT CONCENTRATE (February 16, 1994)
  • K884660 — BIOSONIC ULTRASONIC CLEANING SYSTEM (March 16, 1989)

FDA data resources