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FDA 510(k)

Applied Medical Laparoscopic Linear Cutter

K-Number: K190331 · 2019-11-22

ApplicantApplied Medical Resources Corporation
Decision Date2019-11-22
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Applied Medical Laparoscopic Linear Cutter is a medical device manufactured by Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2019-11-22 under approval number K190331. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Applied Medical Laparoscopic Linear Cutter?

Applied Medical Laparoscopic Linear Cutter is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Applied Medical Resources Corporation. The 510(k) number is K190331.

When was Applied Medical Laparoscopic Linear Cutter approved by the FDA?

Applied Medical Laparoscopic Linear Cutter received FDA 510(k) clearance on 2019-11-22, under approval number K190331.

What company makes Applied Medical Laparoscopic Linear Cutter?

Applied Medical Laparoscopic Linear Cutter is manufactured by Applied Medical Resources Corporation.

What is the FDA product code for Applied Medical Laparoscopic Linear Cutter?

The FDA product code for Applied Medical Laparoscopic Linear Cutter is GDW.

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Related Devices (Code: GDW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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