510(k) Report

FDA applicant

Escala Medical

Misgav, IL3 decisions2022–20260 recalls

FDA records 3 decisions for Escala Medical (Misgav, IL) from 2022 to 2026: 3 510(k) clearances. All are in product code PBQ (Fixation, Non-Absorbable Or Absorbable, For…). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Escala Medical, Ltd.”.

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

FDA decisions per year

1in 2023

2022: 12023: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

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Which product codes does it file in?

  • PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 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.

  • K230730ApyxEscala Medical · 20231cites it
  • K213783ApyxEscala Medical · 20221cites it

What has FDA decided for it lately?

  • K260380MenditEscala Medical, Ltd. · 2026
  • K230730ApyxEscala Medical · 2023
  • K213783ApyxEscala Medical · 2022

All 2 as Escala Medical →The one decision as Escala Medical, Ltd. →