Encision, Inc.
Boulder, CO, US
ENCISION, INC. appears in FDA device records in Boulder, CO. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 26 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 10 510(k) clearances for Encision, Inc. between 2007 and 2020. The busiest year on record is 2009, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201018 | Encision AEM enTouch 2X Scissor | GEI | Substantially Equivalent | |
| K140006 | ENDOSHIELD BURN PROTECTION SYSTEM | GEI | Substantially Equivalent | |
| K131949 | AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES | GEI | Substantially Equivalent | |
| K122383 | EM3 AEM MONITOR AEM CONNECTORS | GEI | Substantially Equivalent | |
| K122580 | AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES | GEI | Substantially Equivalent | |
| K093622 | AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 | GEI | Substantially Equivalent | |
| K100711 | SUCTION IRRIGATION ELECTRODES AND ADAPTERS | GEI | Substantially Equivalent | |
| K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES | GEI | Substantially Equivalent | |
| K090979 | DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES | GCJ | Substantially Equivalent | |
| K072789 | DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1722040 | 1000117361 | ENCISION, INC. | 6797 WINCHESTER CIR., BOULDER, CO 80301 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 26| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1951-2012 | 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 tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. | 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. | Class II | Terminated | |
| Z-3097-2011 | Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301. | Electrode tips have been reported breaking off during use or cleaning. | Terminated | ||
| Z-3096-2011 | Encision AEM Suction Irrigation Electrode, J-Hook, REF ES3884. Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. | Electrode tips have been reported breaking off during use or cleaning. | Terminated | ||
| Z-3095-2011 | Encision AEM Suction Irrigation Electrode, L-Hook, REF ES3883, Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. | Electrode tips have been reported breaking off during use or cleaning. | Terminated | ||
| Z-3094-2011 | Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882, Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. | Electrode tips have been reported breaking off during use or cleaning. | Terminated | ||
| Z-3093-2011 | 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 during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor. | Electrode tips have been reported breaking off during use or cleaning. | Terminated | ||
| Z-2400-2011 | ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures | Sterility may be compromised due to holes in packaging. | Terminated | ||
| Z-2399-2011 | ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures | Sterility may be compromised due to holes in packaging. | Terminated | ||
| Z-2398-2011 | ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures | Sterility may be compromised due to holes in packaging. | Terminated | ||
| Z-2397-2011 | ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures | Sterility may be compromised due to holes in packaging. | Terminated | ||
| Z-2396-2011 | ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures | Sterility may be compromised due to holes in packaging. | Terminated | ||
| Z-2395-2011 | 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. | Terminated | ||
| Z-1546-2010 | AEM Disposable Electrode, L-Wedge, 45cm, REF ES0312-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. | Electrosurgical electrode tip insulation may crack and break off during use. | Terminated | ||
| Z-1545-2010 | AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. | Electrosurgical electrode tip insulation may crack and break off during use. | Terminated | ||
| Z-1544-2010 | AEM Disposable Electrode, L-Diamond, 35cm, REF ES0311, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. | Electrosurgical electrode tip insulation may crack and break off during use. | Terminated | ||
| Z-1543-2010 | AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45, Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. | Electrosurgical electrode tip insulation may crack and break off during use. | Terminated | ||
| Z-1542-2010 | AEM Disposable Electrode, J-Hook, 35cm, REF ES0310, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. | Electrosurgical electrode tip insulation may crack and break off during use. | Terminated | ||
| Z-1541-2010 | AEM Disposable Electrode, Flat J-Hook, 35cm, REF ES0309, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. | Electrosurgical electrode tip insulation may crack and break off during use. | Terminated | ||
| Z-1540-2010 | AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. | Electrosurgical electrode tip insulation may crack and break off during use. | Terminated | ||
| Z-1539-2010 | 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 electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. | Electrosurgical electrode tip insulation may crack and break off during use. | Terminated | ||
| Z-1132-04 | Encision ES4107 Disposable AEM Cord, Sterile. | Firm found pinholes in packaging which would compromise sterility. | Terminated | ||
| Z-1074-04 | AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable. | Electrosurgical tip may break or come off during use. | Terminated | ||
| Z-1052-03 | EM2M 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. | Terminated | ||
| Z-1051-03 | EM2+A NC AEM Monotor (NON-COM) | Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes. | Terminated | ||
| Z-1050-03 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain