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FDA 510(k)

PIGTAIL STENTS

K-Number: K821819 · 1982-08-20

Decision Date1982-08-20
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PIGTAIL STENTS is the device name listed in this FDA 510(k) record. The listed applicant is American Endoscopy, Inc.. It received FDA 510(k) clearance on 1982-08-20 under 510(k) number K821819. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIGTAIL STENTS?

PIGTAIL STENTS is a medical device that received FDA 510(k) clearance on 1982-08-20. The listed applicant is American Endoscopy, Inc.. The 510(k) number is K821819.

When did PIGTAIL STENTS receive FDA 510(k) clearance?

PIGTAIL STENTS received FDA 510(k) clearance on 1982-08-20, under 510(k) number K821819.

Who is the listed applicant for PIGTAIL STENTS?

The FDA 510(k) record lists American Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIGTAIL STENTS?

The FDA product code for PIGTAIL STENTS is FGE.

Related Clinical Trials

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.

Other records listing American Endoscopy, Inc. 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.

View all 19 devices →

Related Devices (Code: FGE)

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

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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