Cleared Traditional

K093622 - AEM MONITORING SYSTEM

K093622 is the FDA 510(k) clearance for AEM MONITORING SYSTEM by Encision, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K093622 · Encision, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
270d
Days
Class 2
Risk

K093622 is an FDA 510(k) clearance for the AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Encision, Inc. (Boulder, US). The FDA issued a Cleared decision on August 20, 2010 after a review of 270 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Encision, Inc. devices

Submission Details

510(k) Number K093622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2009
Decision Date August 20, 2010
Days to Decision 270 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 115d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1119
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K093622.
ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
K101520 · Ethicon Endo-Surgery, Inc. · Dec 2010
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
K101534 · Conmedcorp · Nov 2010
LAPAROSCOPIC DISSECTOR
K103282 · Applied Medical Resources Corp. · Nov 2010
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
K101108 · Erbe USA, Inc. · Jul 2010
PK SUPERPULSE SYSEM GENERATOR MODEL 744000
K100816 · Gyrus Acmi, Inc. · Jul 2010
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214
K100638 · Depuy Mitek, A Johnson & Johnson Company · Jun 2010