BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    INTERSURGICAL LTD.

    Reg #: 3002807267 · FEI: 3002807267 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    111
    Establishment Types
    5
    Classifications
    33

    Registration Details

    Registration Name
    INTERSURGICAL LTD.
    Registration Number
    3002807267
    FEI Number
    3002807267
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CRANE HOUSE MOLLY MILLARS LN
    City
    WOKINGHAM, BERKSHIRE
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K121026

    Owner / Operator

    Firm Name
    INTERSURGICAL LTD.
    Operator Number
    9037658
    Address
    CRANE HOUSE MOLLY MILLARS LN, --
    City
    BERKSHIRE
    State
    Wokingham
    Postal Code
    RG41 2RZ
    Country
    GB
    Correspondent
    Ivan Seniut

    US Agent

    Business Name
    Intersurgical Inc
    Contact Name
    Kerrie Campbell
    Address
    5010 Campuswood Dr, Ste 102
    City
    East Syracuse
    State
    NY
    ZIP
    13057
    Country
    US
    Email
    [email protected]
    Phone
    315 9757022 ext. 500

    Products

    Device Name Product Code
    Filter, Bacterial, Breathing-Circuit CAH
    Mask, Oxygen, Low Concentration, Venturi BYF
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Tubing, Pressure And Accessories BYX
    Nebulizer (Direct Patient Interface) CAF
    Connector, Airway (Extension) BZA
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Absorbent, Carbon-Dioxide CBL
    Airway, Oropharyngeal, Anesthesiology CAE
    Cannula, Nasal, Oxygen CAT
    Mask, Oxygen, Non-Rebreathing KGB
    Catheters, Suction, Tracheobronchial BSY
    Stylet, Tracheal Tube BSR
    Laryngoscope, Rigid CCW
    Support, Breathing Tube JAY
    Protector, Hearing (Insert) EWD
    Valve, Non-Rebreathing CBP
    Clip, Nose BXJ
    Strap, Head, Gas Mask BTK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Mask, Gas, Anesthetic BSJ
    Catheter And Tip, Suction JOL
    Toothbrush, Manual EFW
    Spirometer, Diagnostic BZG
    Mask, Oxygen BYG
    Mouthpiece, Breathing BYP
    Absorber, Carbon-Dioxide BSF
    Bag, Reservoir BTC
    Anesthesia Breathing Circuit Kit (Adult & Pediatric) OFP
    Drain, Tee (Water Trap) BYH
    Lubricant, Patient KMJ

    Proprietary Names

    Flo-Guard, 1690000 1400024, 1400028, 1400031, 1400035, 1400040, 1400050, 1400060 Filta-Therm, 1941000 Smoothbore bilevel breathing system, 5005000, 5018000, 5018011, 5118001, 5804000, 5805000 1573000, 1574000, 2000058, 2900000, 2901000, 2902000, 2903000, 2930000, 2300000 1526000, 2151800, 2152000, 6203000 2010257, 2010258, 2920010, 2920310 4510000 5805030, 5805031, 5018000S, 2121000, 2142000, 2010000 2000000, 2158000 5191850, 5194850 2026030, 2026035 2026310, 2026000, 2060310, 5025000, 5025310, 5026000 2310000 Inter-Therm Mini Pediatric HMEF, 1331000S, 1332000S 1174000, 1174003, 1174021, 1174010 1455002, 1503000 1402000, 1402004, 1402018, 1417000, 1453013, 1453014, 1453015, 1454013, 1454015, 1454017, 1455000, 1455001 One way valve, 1950000, 1952000, 1954000 Straight connector, 1945000, 1946000 Hydro-Therm 3 HME with luer port, 1560000 1442000, 1850000, 1855000, 1873000, 1874000, 1875000, 1875001, 1875020, 1875000S, 1875001S, 1875020S Spherasorb, LoFloSorb, Intersorb Plus 2173000, 2175000, 2178000, 2179000 1344000S, 1344007S, 1344711S Inter-Therm HMEF & Inter-Guard Filter 1341000S, 1341007S, 1341011S, 1341580S 8004003, 8004050, 8005000, 8005003, 8005050, 8015000, 8015002 8001000, 8001002, 8002000, 8002001, 8002002, 8003000, 8003003, 8003050, 8004000 airway support strap, 8800000 8201000, 8202000, 8203000, 8204000, 8205000, 8215000, 8225000, 8603000, 8604000, 8605000 i gel Supraglottic Airway, i gel plus Supraglottic Airway, i-gel O2 Resus Pack i-gel Plus anaesthesia, 8903000, 8904000, 8905000 8003001, 8003002, 8004001, 8004002, 8005001, 8005002 Guedel airway, Layrngeal Mask Airway, Solus Flexible i-gel Plus Resus Pack, 8803030, 8804030, 8805030 1000035, 1100050, 1110055, 1111065, 1111570, 1112080, 1113090, 1114100, 1115120 8025000, 8025001, 8025002 8703030, 8704030, 8705030 8903030, 8904030, 8905030 8201030, 8202030, 8203030, 8204030, 8205030, 8215030, 8225030 1160000,1160001,1160002 1161000, 1163000 ,1165000, 1165002, 1166000, 1167000 1164000, 1165005, 1165013, 7300000, 7301000, 7302000, 7300001, 7301001, 7302001 1192000 3241004, 3241005, 3241006, 3241007, 3720000, 3720001, 3720002, 3720003, 3720004, 3720005, 3720006, 3720007 3721000, 3721001, 3721002, 3721003, 3721004, 3721005, 3721006, 3721007 3240000, 3240001, 3240002, 3240003, 3240004, 3240005, 3240006, 3240007, 3241000, 3241001, 3241002, 3241003 6000500, 6000600, 6000700, 6000800, 6001000 8070006, 8070010, 8070015, 8080006, 8080010, 8080014, 8080015, 8090015 Clear-Therm 3 HMEF with and without luer port and retainable cap, 1541000 Clear-Guard 3, 1544000, 1545000 8008000 i-view laryngoscope 1990000, 1992000, 1993001, 1993000, 1995000, 1997000, 1997000S 1943000, 1947001, 1947003, 1948000, 1949000, 1959000, 3504000S, 1660000, 0556030 Double swivel elbow, 1899000 1966000, 1966001, 1967000, 1968000, 1969000, 1970000, 1971000 3505000, 3506000, 3514000, 3516000, 3521000, 3532000, 5802801, 5802802, 5807000 1974000, 1975000, 1978000, 1979000, 1980000, 1981000, 1982000 3501000, 3502000, 3504000, 3511000, 3521000 1568000, 1661000, 1663000, 1664000, 1701000, 1702000, 1703000, 1704000 2710000, 2712000, 2713000, 2714000, 9747000, 1947000, 1948000, 3520000 1705000, 1706000, 1800000, 1802000, 1891000, 1893000, 1897000, 1898000 1960000, 1961000, 1962000, 1963000, 1964000, 1964001, 1965000 Superset double swivel elbow catheter mount, 3512000 1983000, 1984000, 1985000, 1986000, 1988000, 1989000, 1991000 1900000, 1901000, 1902000, 1903000, 1926000, 1927000, 1929000, 1933000 5904000, 5905000 Tube management clip system, 2314000, 2315000, 2316000, 2317000, 2318000, 2319000 Tube management grip, 2321000 CP908-Earplugs Clear-Therm Micro HMEF, 1441000 Exhalation Valves, 5191000, 5113018, 5182000, 5183000, 5183010 TNI Clear-Guard™3 angled breathing filter 1435000, 1691040 Hydro-Guard & Air-Guard Breathing Filters, 1745000, 1745002, DYNJAAHF, 1745801, 1790000 Harness for CPAP adult mask, 2223000, 2224000 1144015, 1144016, 1144017, 1143018 2725000, 2731000, 2734000 1142035, 1143035, 1143038 1142015, 1142016, 1143017, 1143015, 2734100 1220000, 1221000, 1222000, 1223000, 1224000, 1225000, 1226000 7290000, 7291000, 7292000, 7292001, 7293000, 7293001, 7294000, 7295000, 7295001, 7296000, 7394000, 7394001 1514000, 1515000, 1516000, 1517000 1511111, 1512111, 1513111, 1514111, 1515111, 1516111, 1517111 OroCare™ Sensitive oral suction wand, 3017000 OroCare™ suction control valve flexible, stepped connector 3023000 OroCare™ suction line splitter , 3022000 OroCare™ Aspire suction toothbrush, 3016000 OroCare™ suction control valve flexible, flexible connector 3024000 Filta-Guard breathing filters, 1944000 Filta-Therm Breathing Filters, 1942000 OroCare™ Mini toothbrush, 3011000 1691050, 1691051, 1691052, 1691053 1691010, 1691011, 1691012, 1691013, 1691014, 1691016 1691000, 1691001, 1691002, 1691003, 1691004, 1691005, 1691006, 1691007, 1691009 Clear-Guard Midi, 1644000 Clear-Therm Mini HMEF, 1831000 1137016, 1145000, 1181017, 1188015, 1190015, 1196015, 1196019, 1198015, 1200050, 1206000, 1137016 1135015, 1135017, 1136015, 1141015, 1141035, 1181015 1691020 1477003, 1930000, 1931000, 1937000, 1938000 SmartCan™ Spherasorb™ , 2169001, SmartCan™ LoFloSorb™, 2169003 2186000, 2188000, 2191001, 2193001, 2196000, 2198000, 2199001, 2199003 2820000, 2830000 2158010 2153000 5805009 1911000, 1912000, 1915000, 1916000 One-way valve, 1953000, 1921000 Optilube™, lubricant , 5469000

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device