Encision, Inc.
FDA Regulatory Profile
Encision, Inc. has 1 FDA recall, 4 inspections, 11 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1951-2012 · Class II · Jun 15, 2012
- Latest inspection
- Sep 20, 2019 · NAI
- Latest 510(k)
- Jul 15, 2020
Reviewing Encision, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Request a free FDA snapshot
Or get Encision, Inc.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 11 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 4 | Oct 26, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1951-2012 | Class II | AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM… | Jun 15, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Sep 20, 2019 | Boulder, CO | Devices | No Action Indicated (NAI) | 1000117361 |
| Oct 19, 2015 | Boulder, CO | Devices | Voluntary Action Indicated (VAI) | 1000117361 |
| Dec 7, 2012 | Boulder, CO | Devices | No Action Indicated (NAI) | 1000117361 |
| Dec 2, 2009 | Boulder, CO | Devices | Voluntary Action Indicated (VAI) | 1000117361 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201018 | Encision AEM enTouch 2X Scissor | Jul 15, 2020 |
| K191612 | Encision AEM Monopolar Laparoscopic Instruments and Accessories | Mar 20, 2020 |
| K140006 | ENDOSHIELD BURN PROTECTION SYSTEM | Jun 16, 2014 |
| K131949 | AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES | Aug 26, 2013 |
| K122383 | EM3 AEM MONITOR AEM CONNECTORS | Jan 10, 2013 |
| K122580 | AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES… | Nov 9, 2012 |
| K093622 | AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 | Aug 20, 2010 |
| K100711 | SUCTION IRRIGATION ELECTRODES AND ADAPTERS | Jun 9, 2010 |
| K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES | Aug 17, 2009 |
| K090979 | DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES | May 28, 2009 |
| K072789 | DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES | Oct 19, 2007 |