FDA 510(k) clearance · back to tracker

Reprocessed DePuy Mitek Ablation Wand

Renovo, Inc. cleared K173740 on 2018-03-19, decision: substantially equivalent

K-number

K173740

Sponsor

Renovo, Inc.

Device

Reprocessed DePuy Mitek Ablation Wand

Class

Class II

Decision

Substantially Equivalent

Decision date

2018-03-19

Product code

NUJ

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K173740on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K173740 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.