510(k) Report

FDA applicant

270surgical, Ltd.

Natanya, IL2 decisions2019–20210 recalls

FDA records 2 decisions for 270surgical, Ltd. (Natanya, IL) from 2019 to 2021: 2 510(k) clearances. All are in product code HET (Laparoscope, Gynecologic (And Accessories)). Its devices cite 2 predicates, 1 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, obstetrics and gynecology panel, where it files most

How often FDA has decided 270surgical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 12021: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — 270surgical, Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HETLaparoscope, Gynecologic (And Accessories)2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K190190WV1 Endoscope270surgical, Ltd. · 20191cites it

What has FDA decided for it lately?

  • K210104SurroundScope System270surgical, Ltd. · 2021
  • K190190WV1 Endoscope270surgical, Ltd. · 2019

All 2 as 270surgical, Ltd. →