FDA applicant

Viveve Medical, Inc.

Englewood, CO4 decisions2019–20210 recalls

FDA records 4 decisions for Viveve Medical, Inc. (Englewood, CO) from 2019 to 2021: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 66 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Viveve Medical”.

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 Viveve Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019high 2 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Viveve Medical, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Viveve Medical, 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 “Viveve”

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

Viveve, Inc. 3

Viveve Medical, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Viveve”