FDA applicant

Sharp Medical Prducts, LLC

Scottsdale, AZ1 decision2015–20151 recall

FDA records 1 decision for Sharp Medical Prducts, LLC (Scottsdale, AZ) in 2015: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Sharp Medical Prducts, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2021

2015high 1 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Sharp Medical Prducts, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Sharp”

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

Sharp Electronics Corp. 10 Sharp Corporation 2 Sharp-Trap, Inc. 1 Sharp Safe, Inc. 1

Sharp Medical Prducts, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sharp”