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510(k) K092387

MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM by Minntech Corp. — Product Code FEB

K092387 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 5, 2010. The device falls under product code FEB (Accessories, Cleaning, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Minntech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2010
Date Received
August 5, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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 Minntech Corp.

  • K120306 — RAPICIDE OPA-28 (September 27, 2012)
  • K071298 — HF JUNIOR HEMOFILTER (August 8, 2007)
  • K050952 — HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR (January 31, 2006)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K014016 — ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (February 1, 2002)
  • K991137 — ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER (June 8, 2000)
  • K000028 — RENAFLO II HF 2000 HEMOFILTER (April 4, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K983126 — FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS (March 8, 1999)
  • K983085 — HEMOCOR HPH 700 HEMOCONCENTRATOR (November 13, 1998)

Other clearances for product code FEB

  • K241168 — System 83 Revolve Endoscope Washer/Disinfector (December 19, 2024)
  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (June 30, 2023)
  • K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
  • K201920 — Endoscope Reprocessor OER-Elite (September 1, 2020)
  • K173590 — System 83 Plus Washer/Disinfector (March 30, 2020)
  • K190969 — ENDOSCOPE REPROCESSOR OER-Elite (July 9, 2019)
  • K181472 — AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (April 23, 2019)
  • K181865 — Acu-sInQ Complete Endoscope Cleaning Aid System (December 14, 2018)
  • K172677 — Advantage Plus Pass-Thru (December 19, 2017)

FDA data resources