510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Wassenburg Medical B.V.

Dodewaard Gelderland, NL

WASSENBURG MEDICAL B.V. appears in FDA device records in Dodewaard Gelderland, NL. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
4
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to Wassenburg Medical B.V. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Custom Ultrasonics, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 7 510(k) clearances for Wassenburg Medical B.V. between 1984 and 2024. The busiest year on record is 1984, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Wassenburg Medical B.V., by decision year
YearClearances
19841
19981
20071
20131
20171
20201
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241168System 83 Revolve Endoscope Washer/DisinfectorFEBSubstantially Equivalent
K173590System 83 Plus Washer/DisinfectorFEBSubstantially Equivalent
K162120Scope-Assist Flushing SinkFEBSubstantially Equivalent
K122172SYSTEM 83 PLUSFEBSubstantially Equivalent
K061430SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTORFEBSubstantially Equivalent
K983017MODIFICATION TO SYSTEM 83 PLUSNVESubstantially Equivalent
K842754CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2FLGSubstantially Equivalent

Registered establishments

FDA registered establishments for Wassenburg Medical B.V., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30040574053004057405WASSENBURG MEDICAL B.V.Edisonring 9, Dodewaard Gelderland 6669 NA NL2026
30070822522523209Wassenburg Medical, Inc.144 Railroad Drive, Ivyland, PA 18974 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2130-2016The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.Class IITerminated
Z-0426-2014Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution.Class IITerminated
Z-1182-2008System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PAInadvertent selection of the "wash" cycleTerminated
Z-0770-200783 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.The device was marketed without a 510kTerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain