510(k) K841331

OLYMPUS KC-10 MOBILE DISINFEC-STAT by Keymed, Inc. — Product Code NZA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 19, 1984
Date Received: April 2, 1984
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)
K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (June 17, 1986)
K851149 — KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (November 26, 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)
K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (June 17, 1986)