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510(k) K860704

THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND by Keymed, Inc. — Product Code NZA

K860704 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND". The FDA issued a decision of Substantially Equivalent on June 17, 1986. The device falls under product code NZA (Accessories, Germicide, Cleaning, For Endoscopes), a Class II device regulated under 21 CFR 876.1500. Keymed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1986
Date Received
February 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Germicide, Cleaning, For Endoscopes
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • K861147 — UCS-2, ULTRASONIC CLEANING SOLUTION (June 23, 1986)
  • K851149 — KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (November 26, 1985)
  • K854304 — KEYMED OFFICE COUCH (November 12, 1985)

Other clearances for product code NZA

  • K232918 — enspire 300 Series Automated Endoscope Reprocessor (October 3, 2023)
  • K230560 — enspire 300 Series Automated Endoscope Reprocessor System (July 21, 2023)
  • K220361 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (March 10, 2022)
  • K203223 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (January 28, 2021)
  • K200989 — Reliance Endoscope Processing System (May 14, 2020)
  • K123768 — RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM (July 26, 2013)
  • K110453 — RELIANCE ENDOSCOPE PROCESSING SYSTEM (March 16, 2011)
  • K102244 — RELIANCE ENDOSCOPE PROCESSING SYSTEM (December 3, 2010)
  • K040049 — THE RELIANCE ENDOSCOPE PROCESSING SYSTEM (December 17, 2004)
  • K841331 — OLYMPUS KC-10 MOBILE DISINFEC-STAT (July 19, 1984)

FDA data resources