510(k) Report

FDA applicant

Obp Medical

Lawerence, MA1 decision2009–20090 recalls

FDA records 1 decision for Obp Medical (Lawerence, MA) in 2009: 1 510(k) clearance. All are in product code HIH (Hysteroscope (And Accessories)). 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 Obp Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Obp Medical by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HIHHysteroscope (And Accessories)1decision

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.

  • K091838Obp Self Sealing Endoscopic Seal with Luer LockObp Medical · 20092cite it

What has FDA decided for it lately?

  • K091838Obp Self Sealing Endoscopic Seal with Luer LockObp Medical · 2009

The one decision as Obp Medical →