510(k) Report

FDA applicant

SmartsurgN, Inc.

San Jose, CA3 decisions2022–20260 recalls

FDA records 3 decisions for SmartsurgN, Inc. (San Jose, CA) from 2022 to 2026: 3 510(k) clearances. Most are in product codes OWN (Confocal Optical Imaging) and HIF (Insufflator, Laparoscopic). Since 2016 its 510(k)s took a median of 347 days from receipt to decision, against 63 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Smartsurgn Incorporated”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2025

2022: 12025: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — SmartsurgN, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like SmartsurgN, 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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Which product codes does it file in?

  • OWNConfocal Optical Imaging2decisions
  • HIFInsufflator, Laparoscopic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 347 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 63 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K213943SmartSurgN Visualization SystemSmartsurgn Incorporated · 20221cites it

What has FDA decided for it lately?

  • K242163SmartSurgN Visualization SystemSmartsurgN, Inc. · 2026
  • K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc. · 2025
  • K213943SmartSurgN Visualization SystemSmartsurgn Incorporated · 2022

All 2 as SmartsurgN, Inc. →The one decision as Smartsurgn Incorporated →