Cleared Traditional

K173740 - Reprocessed DePuy Mitek Ablation Wand

K173740 is the FDA 510(k) clearance for Reprocessed DePuy Mitek Ablation Wand by Renovo, Inc.. It is a Class 2 General & Plastic Surgery device (product code NUJ) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K173740 · Renovo, Inc. · General & Plastic Surgery device
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Mar 2018
Decision
102d
Days
Class 2
Risk

K173740 is an FDA 510(k) clearance for the Reprocessed DePuy Mitek Ablation Wand. Classified as Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (product code NUJ), Class II - Special Controls.

Submitted by Renovo, Inc. (Bend, US). The FDA issued a Cleared decision on March 19, 2018 after a review of 102 days - within the typical 510(k) review window.

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 Renovo, Inc. devices

Submission Details

510(k) Number K173740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2017
Decision Date March 19, 2018
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.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 Consultant

Medical Device Academy, Inc.
Robert V. Packard

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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