510(k) Report

FDA applicant

Dalim Surgnet Corporation

Brea, CA2 decisions2010–20110 recalls

FDA records 2 decisions for Dalim Surgnet Corporation (Brea, CA) from 2010 to 2011: 2 510(k) clearances. Most are in product codes OTJ (Laparoscopic Single Port Access Device) and GCJ (Laparoscope, General & Plastic Surgery). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Dalim Surgnet Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 12011: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Dalim Surgnet Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dalim Surgnet Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OTJLaparoscopic Single Port Access Device1decision
  • GCJLaparoscope, General & Plastic Surgery1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K112196OctotmportDalim Surgnet Corporation · 20111cites it
  • K100045OCTODalim Surgnet Corporation · 20101cites it

What has FDA decided for it lately?

  • K112196OctotmportDalim Surgnet Corporation · 2011
  • K100045OCTODalim Surgnet Corporation · 2010

All 2 as Dalim Surgnet Corporation →

Other applicant names beginning “Dalim”

FDA records each applicant name separately; these may or may not be the same firm.

Dalim Tissen Co., Ltd. 1Dalim Medical Corp. 1