Cleared Traditional

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated (K153265) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153265 · New Deantronics Taiwan , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
54d
Days
Class 2
Risk

K153265 is an FDA 510(k) clearance for the New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by New Deantronics Taiwan , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on January 5, 2016 after a review of 54 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 New Deantronics Taiwan , Ltd. devices

Submission Details

510(k) Number K153265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2015
Decision Date January 05, 2016
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 695
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K153265.
Arthrex Synergy RF System
K161581 · Arthrex, Inc. · Sep 2016
LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
K160331 · Covidien · Aug 2016
BiZact Open Sealer/Divider
K160539 · Covidien · Jun 2016
LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip
K150835 · Covidien · Oct 2015
CLICKLINE Scissor Insert for Single Use
K151044 · KARL STORZ Endoscopy-America, Inc. · Oct 2015
Valleylab FT10 Electrosurgical Platform
K151649 · Covidien · Sep 2015