Cleared Traditional

K161305 - Habib EUS RFA

K161305 is an FDA 510(k) clearance for Habib EUS RFA, manufactured by Emcision , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K161305 · Emcision , Ltd. · General & Plastic Surgery device
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Jul 2016
Decision
58d
Days
Class 2
Risk

K161305 is an FDA 510(k) clearance for the Habib EUS RFA. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Emcision , Ltd. (London, GB). The FDA issued a Cleared decision on July 7, 2016 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emcision , Ltd. devices

FDA 510(k) Submission Details - K161305

510(k) Number K161305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2016
Decision Date July 07, 2016
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

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.

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