510(k) Report

FDA applicant

Metamorphic Surgical Devices, LLC

Pittsburgh, PA1 decision2000–20000 recalls

FDA records 1 decision for Metamorphic Surgical Devices, LLC (Pittsburgh, PA) in 2000: 1 510(k) clearance. All are in product code QEW (Peripheral Mechanical Thrombectomy With…). 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, cardiovascular panel, where it files most

How often FDA has decided Metamorphic Surgical Devices, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Metamorphic Surgical Devices, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Metamorphic Surgical Devices, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QEWPeripheral Mechanical Thrombectomy With Aspiration1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K991093MSD Embolectomy BasketMetamorphic Surgical Devices, LLC · 20002cite it

What has FDA decided for it lately?

  • K991093MSD Embolectomy BasketMetamorphic Surgical Devices, LLC · 2000

The one decision as Metamorphic Surgical Devices, LLC →