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FDA 510(k)

GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00

K-Number: K082102 · 2010-06-14

ApplicantApollo Endosurgery, Inc.
Decision Date2010-06-14
Product CodeFED
Advisory CommitteeGU
DecisionUnknown

Device Summary

GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2010-06-14 under 510(k) number K082102. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00?

GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 is a medical device that received FDA 510(k) clearance on 2010-06-14. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K082102.

When did GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 receive FDA 510(k) clearance?

GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 received FDA 510(k) clearance on 2010-06-14, under 510(k) number K082102.

Who is the listed applicant for GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00?

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

What is the FDA product code for GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00?

The FDA product code for GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 is FED.

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Other records listing Apollo Endosurgery, Inc. as applicant

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Related Devices (Code: FED)

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

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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