FDA applicant
Encision, Inc.
FDA records 11 decisions for Encision, Inc. (Boulder, CO) from 2007 to 2020: 11 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 16 predicates, 8 of them its own earlier devices. 14 recalls are linked to its devices.
FDA’s records also spell it “Encision Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Encision, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Encision, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report