Data / Medical devices / United Kingdom / Intersurgical Ltd.
Intersurgical Ltd.: FDA-registered device maker in Wokingham, Berkshire, United Kingdom, 17 510(k) clearances
Intersurgical Ltd. is registered with the FDA (registration 3002807267) in Wokingham, Berkshire, United Kingdom. It lists 32 device types. The FDA files 17 510(k) clearances under its listings, the newest dated June 15, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002807267
- Address
- Crane House Molly Millars LN, Wokingham, Berkshire, United Kingdom, RG41 2RZ
- Owner or operator
- INTERSURGICAL LTD. (9037658)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- August 14, 2003
- Registered through
- 2027
- Brand names listed
- 1000035, 1100050, 1110055, 1111065, 1111570, 1112080, 1113090, 1114100, 1115120, 1135015, 1135017, 1136015, 1141015, 1141035, 1181015, 1137016, 1145000, 1181017, 1188015, 1190015, 1196015, 1196019, 1198015, 1200050, 1206000, 1137016, 1142015, 1142016, 1143017, 1143015, 2734100, 1142035, 1143020, 1143035, 1143038, 1144015, 1144016, 1144017, 1143018, 1160000,1160001,1160002, 1161000, 1163000 ,1165000, 1165002, 1166000, 1167000 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 15, 2023 | K223258 | TNI Clear-Guard™ 3 angled breathing filter (1545020) | CAH | Substantially Equivalent | Intersurgical , Ltd. | accessdata.fda.gov |
| February 12, 2015 | K141087 | INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF | CAH | Substantially Equivalent | Intersurgical Incorporated | accessdata.fda.gov |
| June 4, 2014 | K132143 | EXHALATION VALVE | CBP | Substantially Equivalent | Intersurgical Incorporated | accessdata.fda.gov |
| December 20, 2012 | K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | CCK | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| November 2, 2012 | K121026 | FLO-GUARD BREATHING FILTER | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| October 29, 2010 | K092451 | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| May 18, 2010 | K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | BZE | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| March 10, 2010 | K092409 | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| May 13, 2004 | K032322 | CLEAR-THERM MICRO HME, MODEL 1441 | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| June 24, 2003 | K024270 | CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| March 14, 2002 | K013123 | EMS PULMONARY FUNCTION TESTING FILTER | BZG | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
| April 30, 1999 | K983610 | CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| May 21, 1993 | K925462 | BREATHING FILTERS 1942T/1941T/2014T | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| June 17, 1992 | K921512 | ENTENDED LINE ACCESSORIES & CONNECTORS | BZA | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| October 23, 1991 | K911422 | DRUG NEBULIZERS | CAF | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| August 26, 1991 | K911427 | BREATHING FILTERS | CAH | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
| June 24, 1991 | K911425 | ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM | BZA | Substantially Equivalent | Intersurgical, Inc. | accessdata.fda.gov |
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Updated June 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.