Atlas FDA

MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM

FDA 510(k) clearance K092387 · decided 2010-04-05

Clearance details

K-number
K092387
Device name
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
Applicant
Minntech Corp.
Decision
Substantially Equivalent
Date received
2009-08-05
Decision date
2010-04-05
Days to decision
243 days
Clearance type
Traditional
Product code
FEB
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Minntech Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
System 83 Revolve Endoscope Washer/Disinfector (K241168)Wassenburg Medical, Inc.2024-12-19
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (K243433)STERIS Corporation2024-12-02
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (K230930)STERIS Corporation2023-06-30
SCOPE BUDDY PLUS Endoscope Flushing Aid (K213833)Medivators, Inc.2022-01-14
Endoscope Reprocessor OER-Elite (K201920)Olympus Medical Systems Corp.2020-09-01
System 83 Plus Washer/Disinfector (K173590)Custom Ultrasonics, Inc.2020-03-30
ENDOSCOPE REPROCESSOR OER-Elite (K190969)Olympus Medical Systems Corp.2019-07-09
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor (K181472)Advanced Sterilization Products (Asp)2019-04-23
Acu-sInQ Complete Endoscope Cleaning Aid System (K181865)STERIS Corporation2018-12-14
Advantage Plus Pass-Thru (K172677)Medivators, Inc.2017-12-19
Scope-Assist Flushing Sink (K162120)Custom Ultrasonics, Inc.2017-04-28
Scope Buddy Plus Endoscope Flushing Aid (K162128)Medivators, Inc.2016-12-21

Recalls involving this device

RecordFirmDate
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the inter recall (Z-2539-2024)Steris Corporation2024-08-08