510(k) Report

FDA applicant

Sac, LLC Dba Pinnacle Medical Surgical

Orlando, FL1 decision2011–20110 recalls

FDA records 1 decision for Sac, LLC Dba Pinnacle Medical Surgical (Orlando, FL) in 2011: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). 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 Sac, LLC Dba Pinnacle Medical Surgical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Sac, LLC Dba Pinnacle Medical Surgical by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery1decision

What has FDA decided for it lately?

  • K101733Reusable, Disposable Laparoscopic Instrument and Surgical Device and AccessoriesSac, LLC Dba Pinnacle Medical Surgical · 2011

The one decision as Sac, LLC Dba Pinnacle Medical Surgical →