Intersurgical, Inc.
Intersurgical, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2013, with 13 FDA device recalls on record.
Top product codes for Intersurgical, Inc.
FDA recalls by Intersurgical, Inc.
10 most recent of 13- Z-2953-2026 — One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
- Z-2952-2026 — One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
- Z-2276-2025 — One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
- Z-2275-2025 — One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
- Z-2102-2025 — i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
- Z-0096-2023 — Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
- 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.
- Z-0786-2020 — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
- Z-0785-2020 — Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.
- Z-0787-2020 — Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Intersurgical, Inc.
- K122077 — MANOMETER
- K122075 — DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
- K121026 — FLO-GUARD BREATHING FILTER
- K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER
- K092129 — INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330
- K092409 — HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
- K032322 — CLEAR-THERM MICRO HME, MODEL 1441
- K024270 — CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
- K990949 — CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT
- K983610 — CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18
- K984481 — EXHALATION VALVE
- K925462 — BREATHING FILTERS 1942T/1941T/2014T
- K921511 — CATHETER MOUNTS -- MODIFICATION
- K921512 — ENTENDED LINE ACCESSORIES & CONNECTORS
- K911422 — DRUG NEBULIZERS
- K911427 — BREATHING FILTERS
- K911421 — CATHETER MOUNTS
- K911425 — ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
Data sourced from openFDA. This site is unofficial and independent of the FDA.