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FDA 510(k)

Laparoscopic Spray Applicator with Spinning Luers

K-Number: K162077 · 2016-08-11

Decision Date2016-08-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Laparoscopic Spray Applicator with Spinning Luers is a medical device manufactured by Micromedics, Inc. (D/B/A Nordson Medical). It received FDA 510(k) clearance on 2016-08-11 under approval number K162077. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laparoscopic Spray Applicator with Spinning Luers?

Laparoscopic Spray Applicator with Spinning Luers is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Micromedics, Inc. (D/B/A Nordson Medical). The 510(k) number is K162077.

When was Laparoscopic Spray Applicator with Spinning Luers approved by the FDA?

Laparoscopic Spray Applicator with Spinning Luers received FDA 510(k) clearance on 2016-08-11, under approval number K162077.

What company makes Laparoscopic Spray Applicator with Spinning Luers?

Laparoscopic Spray Applicator with Spinning Luers is manufactured by Micromedics, Inc. (D/B/A Nordson Medical).

What is the FDA product code for Laparoscopic Spray Applicator with Spinning Luers?

The FDA product code for Laparoscopic Spray Applicator with Spinning Luers is GCJ.

Other Devices by Micromedics, Inc. (D/B/A Nordson Medical)

Related Devices (Code: GCJ)

Official Source

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