Data / Medical devices / United States / Encision, Inc.
Encision, Inc.: FDA-registered device maker in Boulder, CO, United States, 8 510(k) clearances
Encision, Inc. is registered with the FDA (registration 1722040) in Boulder, CO, United States. It lists 1 device type. The FDA files 8 510(k) clearances under its listings, the newest dated July 15, 2020. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1722040
- FEI number
- 1000117361
- Address
- 6797 Winchester Cir., Boulder, CO, United States, 80301
- Owner or operator
- ENCISION, INC. (9003185)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- AEM Burn Protection Disposable System Cable, AEM Cord Adapter, AEM Disposable Monopolar Laparoscopic Electrodes, Cords, and Handpiece, AEM Endoshield 2 Burn Protection System, AEM e-Edge Disposable Scissor Inserts, AEM enTouch 2X Scissor, AEM enTouch Handles, Disposable AEM Cord and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| July 15, 2020 | K201018 | Encision AEM enTouch 2X Scissor | GEI | Substantially Equivalent | Encision, Inc. | accessdata.fda.gov |
| March 20, 2020 | K191612 | Encision AEM Monopolar Laparoscopic Instruments and Accessories | GEI | Substantially Equivalent | Encision Incorporated | accessdata.fda.gov |
| June 16, 2014 | K140006 | ENDOSHIELD BURN PROTECTION SYSTEM | GEI | Substantially Equivalent | Encision, Inc. | accessdata.fda.gov |
| January 10, 2013 | K122383 | EM3 AEM MONITOR AEM CONNECTORS | GEI | Substantially Equivalent | Encision, Inc. | accessdata.fda.gov |
| August 20, 2010 | K093622 | AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 | GEI | Substantially Equivalent | Encision, Inc. | accessdata.fda.gov |
| June 9, 2010 | K100711 | SUCTION IRRIGATION ELECTRODES AND ADAPTERS | GEI | Substantially Equivalent | Encision, Inc. | accessdata.fda.gov |
| August 17, 2009 | K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES | GEI | Substantially Equivalent | Encision, Inc. | accessdata.fda.gov |
| December 30, 1991 | K912780 | MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD | GEI | Substantially Equivalent | Electroscope, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 15, 2012 | 61529 | Class II | Terminated | AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft | Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures. | accessdata.fda.gov |
| August 24, 2011 | 59781 | Not yet classified | Terminated | Encision AEM Suction Irrigation Electrode, L-Diamond, REF ES3881. Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids du | Electrode tips have been reported breaking off during use or cleaning. | accessdata.fda.gov |
| April 7, 2011 | 58518 | Not yet classified | Terminated | ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures | Sterility may be compromised due to holes in packaging. | accessdata.fda.gov |
| April 5, 2010 | 55286 | Not yet classified | Terminated | AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency el | Electrosurgical electrode tip insulation may crack and break off during use. | accessdata.fda.gov |
| July 9, 2004 | 29563 | Not yet classified | Terminated | Encision ES4107 Disposable AEM Cord, Sterile. | Firm found pinholes in packaging which would compromise sterility. | accessdata.fda.gov |
| June 11, 2004 | 29430 | Not yet classified | Terminated | AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable. | Electrosurgical tip may break or come off during use. | accessdata.fda.gov |
| June 23, 2003 | 26604 | Not yet classified | Terminated | EM2 NC AEM Monitor (NON-COM) | Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes. | accessdata.fda.gov |
| January 15, 2003 | 25368 | Not yet classified | Terminated | AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B | Reports of needle fixed-tip electrodes becoming loose or breaking off. | accessdata.fda.gov |
Compare with other makers
Updated July 15, 2020. 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.