Intersurgical Ltd.
East Syracuse, NY, US
INTERSURGICAL LTD. appears in FDA device records in East Syracuse, NY. FDA records list 19 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Intersurgical Ltd. between 1991 and 2023. The busiest year on record is 1991, with 4. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 4 |
| 1992 | 2 |
| 1993 | 1 |
| 1999 | 3 |
| 2003 | 1 |
| 2004 | 1 |
| 2010 | 3 |
| 2012 | 2 |
| 2013 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223258 | TNI Clear-Guard™ 3 angled breathing filter (1545020) | CAH | Substantially Equivalent | |
| K122077 | MANOMETER | CAP | Substantially Equivalent | |
| K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | CCK | Substantially Equivalent | |
| K121026 | FLO-GUARD BREATHING FILTER | CAH | Substantially Equivalent | |
| K092451 | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER | CAH | Substantially Equivalent | |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | BZE | Substantially Equivalent | |
| K092409 | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER | CAH | Substantially Equivalent | |
| K032322 | CLEAR-THERM MICRO HME, MODEL 1441 | CAH | Substantially Equivalent | |
| 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 | |
| K990949 | CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT | CAH | Substantially Equivalent | |
| 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 | |
| K984481 | EXHALATION VALVE | CBP | Substantially Equivalent | |
| K925462 | BREATHING FILTERS 1942T/1941T/2014T | CAH | Substantially Equivalent | |
| K921512 | ENTENDED LINE ACCESSORIES & CONNECTORS | BZA | Substantially Equivalent | |
| K921511 | CATHETER MOUNTS -- MODIFICATION | BZA | Substantially Equivalent | |
| K911422 | DRUG NEBULIZERS | CAF | Substantially Equivalent | |
| K911427 | BREATHING FILTERS | CAH | Substantially Equivalent | |
| K911425 | ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM | BZA | Substantially Equivalent | |
| K911421 | CATHETER MOUNTS | BZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002807267 | 3002807267 | INTERSURGICAL LTD. | CRANE HOUSE MOLLY MILLARS LN, WOKINGHAM, BERKSHIRE RG41 2RZ GB | 2026 | and 22 more, listed in full below |
| 3010741366 | 3010741366 | INTERSURGICAL S.P.A. | Via Tonino Morandi, 12, Mirandola (MO) Italy Modena 41037 IT | 2026 | |
| 1319447 | 1000120301 | INTERSURGICAL, INC. | 5010 Campuswood Dr, Ste 102, East Syracuse, NY 13057 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBLAbsorbent, Carbon-Dioxide
- BSFAbsorber, Carbon-Dioxide
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)
- BTCBag, Reservoir
- CATCannula, Nasal, Oxygen
- JOLCatheter And Tip, Suction
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BXJClip, Nose
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- BYHDrain, Tee (Water Trap)
- CAHFilter, Bacterial, Breathing-Circuit
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CCWLaryngoscope, Rigid
- KMJLubricant, Patient
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- KGBMask, Oxygen, Non-Rebreathing
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- EWDProtector, Hearing (Insert)
- BZGSpirometer, Diagnostic
- BTKStrap, Head, Gas Mask
- BSRStylet, Tracheal Tube
- JAYSupport, Breathing Tube
- FTYTape, Measuring, Rulers And Calipers
- EFWToothbrush, Manual
- BYXTubing, Pressure And Accessories
- ECBUnit, Syringe, Air And/Or Water
- CBPValve, Non-Rebreathing
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2953-2026 | One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device. | Devices could potentially be occluded or partially occluded. | Class II | Open, Classified | |
| Z-2952-2026 | One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. | Devices could potentially be occluded or partially occluded. | Class II | Open, Classified | |
| Z-2276-2025 | One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. | Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection. | Class II | Open, Classified | |
| Z-2275-2025 | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection. | Class II | Open, Classified | |
| Z-2102-2025 | i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy. | Potential for faulty devices as a result of depleted batteries. | Class I | Open, Classified | |
| Z-0096-2023 | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000 | Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient | Class II | Terminated | |
| Z-0753-2021 | Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. | The device was assembled with the incorrect exhalation port which can cause gas leakage. | Class II | Terminated | |
| Z-0787-2020 | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector. | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. | Class II | Terminated | |
| Z-0786-2020 | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector. | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. | Class II | Terminated | |
| Z-0785-2020 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector. | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. | Class II | Terminated | |
| Z-0784-2020 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector. | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. | Class II | Terminated | |
| Z-2302-2018 | Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 | When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient. | Class II | Terminated | |
| Z-0208-2018 | Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management. | A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated. | Class II | Terminated | |
| Z-0518-2012 | The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. | Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain