INTERSURGICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13194471000120301INTERSURGICAL, INC.1Y2026-01-015010 Campuswood Dr, Ste 102 East Syracuse NY US 13057

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
438091309145588K990949CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORTCAH1999-06-15
438091143949102K984481EXHALATION VALVECBP1999-01-29
438091550720567K983610CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18CAH1999-04-30
438091725090096K925462BREATHING FILTERS 1942T/1941T/2014TCAH1993-05-21
438091321678729K911427BREATHING FILTERSCAH1991-08-26
438091890096860K911422DRUG NEBULIZERSCAF1991-10-23
438091268271908K143127CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only styleCCK2015-02-13
438091324203356K141087INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEFCAH2015-02-12
438091552184654K132143EXHALATION VALVECBP2014-06-04
438091064566255K122077MANOMETERCAP2013-01-10
438091115905201K122075DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTERCCK2012-12-20
438091614559111K121747FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKSBZD2013-03-14
438091553889290K121026FLO-GUARD BREATHING FILTERCAH2012-11-02
438091651928058K120463MOJO, VERASEALBZD2012-07-27
438091297319500K092451INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTERCAH2010-10-29
438091143187182K092409HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTERCAH2010-03-10
438091739217657K092129INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330BZE2010-05-18
438092014608193K063806SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTEDCBK2007-05-17
438091741175260K032322CLEAR-THERM MICRO HME, MODEL 1441CAH2004-05-13
438091655709100K031794ENDOFLEX TRACHEAL TUBEBTR2004-03-12
438091507898033K024270CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3CAH2003-06-24
438091035252125
438091041820371
438091059261830
438091071409187
438091093624485
438091096921981
438091128857139
438091141409931
438091163805480
438091191875301
438091276127909
438091300495708
438091343688866
438091364601700
438091463140202
438091506654013
438091590969958
438091620957185
438091623350487
438091660507650
438091689373665
438091703787537
438091728816956
438091816999195
438091863046570
438091896887353
438091949760345
438092056230386
438091058100525
438091162148333
438091213900787
438091342210484
438091716147519
438091943424309
438091980642000
438092000172079

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAH102015-02-12
CCK32015-02-13
CBP22014-06-04
BZD22013-03-14
CAP12013-01-10
BZE12010-05-18
CBK12007-05-17
BTR12004-03-12
CAF11991-10-23

PMN#