510(k) Report

FDA applicant

Renovo, Inc.

Bend, OR6 decisions2017–20180 recalls

FDA records 6 decisions for Renovo, Inc. (Bend, OR) from 2017 to 2018: 6 510(k) clearances. Most are in product codes NUJ (Electrosurgical, Cutting & Coagulation…) and NLM (Laparoscope, General & Plastic Surgery…). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Renovo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2018

2017: 32018: 3
2017high 3 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Renovo, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Renovo, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Renovo”

FDA records each applicant name separately; these may or may not be the same firm.