510(k) Report

FDA applicant

Powermed, Inc.

New Hope, PA1 decision2000–20003 recalls

FDA records 1 decision for Powermed, Inc. (New Hope, PA) in 2000: 1 510(k) clearance. All are in product code GDW (Staple, Implantable). 3 recalls are linked to its devices.

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

FDA decisions per year

No FDA decision for Powermed, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Powermed, Inc. 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?

  • GDWStaple, Implantable1decision

Who builds on its devices?

Later devices cite its devices 7 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.

  • K003277Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33Powermed, Inc. · 20007cite it

What has FDA decided for it lately?

  • K003277Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33Powermed, Inc. · 20003 recalls

The one decision as Powermed, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K003277SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product…Sep 23, 2009
  • K003277SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).Jun 30, 2003
  • K003277SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)Jun 30, 2003