Intersurgical Inc
Summary
- Total Recalls
- 11 (1 Class I)
- 510(k) Clearances
- 19
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2276-2025 | Class II | One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. | June 20, 2025 |
| Z-2275-2025 | Class II | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | June 20, 2025 |
| Z-2102-2025 | Class I | i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to | June 17, 2025 |
| Z-0096-2023 | Class II | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8 | August 29, 2022 |
| Z-0753-2021 | Class II | Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Brea | November 11, 2020 |
| Z-0785-2020 | Class II | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector. | August 7, 2019 |
| Z-0784-2020 | Class II | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector. | August 7, 2019 |
| Z-0787-2020 | Class II | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airw | August 7, 2019 |
| Z-0786-2020 | Class II | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airw | August 7, 2019 |
| Z-2302-2018 | Class II | Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 | April 25, 2018 |
| Z-0208-2018 | Class II | Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric | April 3, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020) | June 15, 2023 |
| K122077 | MANOMETER | January 10, 2013 |
| K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | December 20, 2012 |
| K121026 | FLO-GUARD BREATHING FILTER | November 2, 2012 |
| K092451 | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUAR | October 29, 2010 |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2 | May 18, 2010 |
| K092409 | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILT | March 10, 2010 |
| K032322 | CLEAR-THERM MICRO HME, MODEL 1441 | May 13, 2004 |
| K024270 | CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MO | June 24, 2003 |
| K990949 | CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING POR | June 15, 1999 |
| K983610 | CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS | April 30, 1999 |
| K984481 | EXHALATION VALVE | January 29, 1999 |
| K925462 | BREATHING FILTERS 1942T/1941T/2014T | May 21, 1993 |
| K921511 | CATHETER MOUNTS -- MODIFICATION | June 17, 1992 |
| K921512 | ENTENDED LINE ACCESSORIES & CONNECTORS | June 17, 1992 |
| K911422 | DRUG NEBULIZERS | October 23, 1991 |
| K911427 | BREATHING FILTERS | August 26, 1991 |
| K911425 | ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM | June 24, 1991 |
| K911421 | CATHETER MOUNTS | June 24, 1991 |