Cleared Abbreviated

K170054 - iSurg

K170054 is an FDA 510(k) clearance for iSurg, manufactured by Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Abbreviated 510(k) pathway after a 269-day FDA review.

K170054 · Jaco, LLC Dba Macan Manufacturing and Bna Burz North America · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
269d
Days
Class 2
Risk

K170054 is an FDA 510(k) clearance for the iSurg. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Jaco, LLC Dba Macan Manufacturing and Bna Burz North America (Milton, US). The FDA issued a Cleared decision on October 2, 2017 after a review of 269 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Jaco, LLC Dba Macan Manufacturing and Bna Burz North America devices

FDA 510(k) Submission Details - K170054

510(k) Number K170054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2017
Decision Date October 02, 2017
Days to Decision 269 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Standards-based clearance path.

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.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1303
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K170054.
gi-4000 Electrosurgical Generator
K172805 · United States Endoscopy Group, Inc. · Oct 2017
InMode RF System
K171593 · Inmode MD , Ltd. · Oct 2017
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
K172671 · Conmed Corporation · Oct 2017
TempSure
K171262 · Cynosure, Inc. · Sep 2017
Stryker Integrated Bipolar Cord and Tubing Sets
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AUTOCON III 400
K171717 · KARL STORZ Endoscopy-America, Inc. · Aug 2017