FDA.reportPublic FDA data

HENKE SASS WOLF OF AMERICA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12229971000120548HENKE SASS WOLF OF AMERICA, INC.1Y2026-01-01135 Schofield Ave DUDLEY MA US 01571

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
91951346481481K991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, CHIH1999-10-13
91951754102363K982149SMITH & NEPHEW DYONICS MICROLAPAROSCOPEHET1998-09-10
91951810418326K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
91951424197285K952186HSW GMBH HYSTEROSCOPES & ACCESSORIESHIH1996-02-06
91951242654839K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHIH2018-12-06
91951029938916K122563MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNELHIH2012-09-19
91951105319930K091465MYOSURE ROD LENS HYSTEROSCOPEHIH2009-08-21
91951191984383K082451STRYKER VIDEOSCOPEHET2008-12-16
91951682798927
91951155761015
91951222686365
91951317295312
91951528527443
91951654834086
91952036545260

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIH52018-12-06
HET22008-12-16
EOB11998-08-13

PMN#