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FDA 510(k)

Endoscopic Applicator, 41 cm

K-Number: K172672 · 2017-10-06

Decision Date2017-10-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Endoscopic Applicator, 41 cm is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc. (D/B/A Nordson Medical). It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172672. 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 Endoscopic Applicator, 41 cm?

Endoscopic Applicator, 41 cm is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Micromedics, Inc. (D/B/A Nordson Medical). The 510(k) number is K172672.

When did Endoscopic Applicator, 41 cm receive FDA 510(k) clearance?

Endoscopic Applicator, 41 cm received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172672.

Who is the listed applicant for Endoscopic Applicator, 41 cm?

The FDA 510(k) record lists Micromedics, Inc. (D/B/A Nordson Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoscopic Applicator, 41 cm?

The FDA product code for Endoscopic Applicator, 41 cm is GCJ.

Other records listing Micromedics, Inc. (D/B/A Nordson Medical) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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