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Sign in to claim this brandINVUITY, INC.
US
Last updated May 27, 2026
What INVUITY, INC. makes
The company manufactures reusable sterilization and disinfection containers designed for medical devices, as well as single-use surgical and emergency suction cannulas with integrated illumination. It also produces fibreoptic light cables and surgical instrument fibreoptic lights for operating room use, alongside monopolar electrosurgical electrodes for open-surgery procedures.
All listed devices fall under FDA Class II regulation and are authorised through the 510(k) and UDI pathways. The company’s products are registered with the FDA, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Invuity, Inc. manufacture?
Invuity, Inc. specializes in reusable sterilization and disinfection containers for medical devices, as well as single-use surgical tools. Their product lineup includes illuminating suction cannulas for emergency and surgical procedures, fibreoptic light cables and surgical instrument lights for operating rooms, and monopolar electrosurgical electrodes for open-surgery applications. These devices are designed to support sterilization, illumination, and surgical precision in clinical settings.
Where is Invuity, Inc. based, and what regulatory pathways do its devices follow?
Invuity, Inc. is headquartered in the United States. The company’s devices are primarily authorised through the FDA’s 510(k) pathway and are assigned Unique Device Identifiers (UDIs) as part of the UDI system. Since all listed devices fall under FDA Class II regulation, they undergo premarket notification (510(k)) submissions to demonstrate substantial equivalence to predicate devices before entering the market.
Which regulatory registries or databases list Invuity, Inc.’s medical devices?
Invuity, Inc.’s devices are registered in the FDA’s 510(k) database and the UDI (Unique Device Identifier) system. These registries ensure traceability and compliance tracking for Class II medical devices authorised in the U.S. The FDA maintains these records to monitor device performance, safety, and regulatory status.
How are Invuity, Inc.’s devices classified by the FDA, and why does this matter?
Invuity, Inc.’s devices are classified as FDA Class II, which means they pose moderate risk and require special controls to ensure safety and effectiveness. This classification necessitates premarket submission (like the 510(k)) to demonstrate compliance with regulatory requirements before commercialisation. Class II devices undergo additional scrutiny to balance innovation with patient safety.
What distinguishes Invuity, Inc.’s reusable sterilization containers from single-use surgical devices?
Invuity, Inc. produces both reusable sterilization containers (e.g., trays for medical devices) and single-use surgical tools (e.g., illuminating suction cannulas or electrosurgical electrodes). Reusable containers are designed for repeated cleaning and sterilisation cycles, while single-use devices are intended for one-time clinical use to minimise infection risks. The distinction ensures appropriate sterilisation protocols and patient safety protocols align with device type.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- invuity.com
- —
- —
- [email protected]
- Phone
- 8667117768
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 175697908
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PhotonGuide XT System | Narrow / Angled | FDA UDI | Class I | Unknown |
| Invuity® Sterilization Tray | Small | FDA UDI | Class II | Active |
| Eigr™ Saber Waveguide | Frazier, 12Fr | FDA UDI | Class II | Active |
| Breiten Sterilization Tray | Narrow | FDA UDI | Class II | Active |
| Invuity® Fiber Optic Cable | Single | FDA UDI | Class II | Active |
| PhotonBlade® | PhotonBlade Breast Kit | FDA UDI | Class II | Active |
| Eigr™ Saber Waveguide | Yankauer, Fin Tip | FDA UDI | Class II | Active |
| Invuity® Fiber Optic Sterilization Tray | Large | FDA UDI | Class II | Active |
| PhotonBlade™ | PB1 | FDA UDI | Class II | Active |
| PhotonGuide | Wide / Angled | FDA UDI | Class II | Active |
| Eigr™ Waveguide | Narrow / Flat, LC | FDA UDI | Class II | Active |
| Eigr™ Saber Waveguide | Yankauer, Bulb Tip | FDA UDI | Class II | Active |
| Eikon Sterilization Tray | Narrow | FDA UDI | Class II | Active |
| PhotonGuide | Wide / Angled | FDA UDI | Class II | Active |
| Eigr™ Saber Waveguide | Yankauer, Taper Tip | FDA UDI | Class II | Active |
| PhotonGuide | Narrow / Angled | FDA UDI | Class II | Active |
| PhotonBlade™ | PB1 | FDA UDI | Class II | Active |
| Synthes Fiber Optic Cable | Single | FDA UDI | Class II | Active |
| PhotonSaber Y | Fin Tip | FDA UDI | Class II | Unknown |
| Invuity® Fiber Optic Cable | Bifurcated | FDA UDI | Class II | Active |
| Eigr™ Saber Waveguide | Yankauer, Metal Tip | FDA UDI | Class II | Active |
| PhotonGuide Adapt | PhotonGuide Adapt | FDA UDI | Class II | Unknown |
| Synthes Fiber Optic Cable | Bifurcated | FDA UDI | Class II | Active |
| Invuity® Steam Sterilization Tray | 1.5 x 6 x 10 in | FDA UDI | Class II | Active |
| Breiten Sterilization Tray | Standard | FDA UDI | Class II | Active |
| PhotonGuide XT System | Narrow / Flat | FDA UDI | Class I | Unknown |
| Invuity® Steam Sterilization Tray | 1.5 x 10 x 15 in | FDA UDI | Class II | Active |
| Eigr Surgical Illumination System | K113697 | FDA 510(k) | Class II | Active |
| PhotonBlade | K162053 | FDA 510(k) | Class II | Active |
| PhotonBlade with Smoke Evacuation | K191583 | FDA 510(k) | Class II | Active |
| Invuity Britefield Mcculloch Retractor System | K090070 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Invuity, Inc. has two recall records in the FDA database, both initiated between May 12, 2012, and June 12, 2017, with all records marked as terminated. One recall involved reports of possible unintended energy discharge with the potential for tissue damage, while the other was for the voluntary return of obsolete BriteField Illuminated Suction Devices, which had not been distributed since March 2011 due to the introduction of a successor product.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 12, 2017 | Z-2778-2017 | — | terminated | A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients. |
| May 12, 2012 | Z-0007-2013 | — | terminated | Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time. |