Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807267

FEI Number

3002807267

Entity Name

INTERSURGICAL LTD.

City/State/Country

WOKINGHAM, BERKSHIRE, GB

Establishment Address

CRANE HOUSE MOLLY MILLARS LN, WOKINGHAM, BERKSHIRE RG41 2RZ, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

INTERSURGICAL LTD. (Owner Number: 9037658)

Owner / Operator Contact Address

CRANE HOUSE MOLLY MILLARS LN, --, BERKSHIRE, GB-WOK RG41 2RZ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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-Guard3 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2025-05-16
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2025-05-16
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-12
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2003-08-14
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2025-07-03
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-07-03
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2025-09-22
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2025-05-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-07-03
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2025-09-19
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2003-08-14
CBL	Absorbent, Carbon-Dioxide	Anesthesiology	Class 1	868.5300	2003-08-14
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2025-09-22
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2025-09-19
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-05-16
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2025-05-16
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2022-11-07
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2025-07-03
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-12
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-11-14
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2003-08-14
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2003-08-14
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2026-06-09
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2025-09-22
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2025-09-23
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2025-09-22
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2025-05-16
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2025-09-22
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2025-07-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-05-16
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2008-04-14
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2025-09-23
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-12
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2025-09-23
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2025-05-16
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-12
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2025-05-16

Official Correspondent

Ivan Seniut

US Agent Details

Kerrie Campbell Business: Intersurgical Inc Email: kcampbell@intersurgicalinc.com Phone: (315) 9757022

Related Public Records

Same Entity

INTERSURGICAL LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807267. Last updated year: 2026. Please use registration number 3002807267 when referencing this establishment in official correspondence.