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FDA 510(k)

SUMO ACCESS AND TISSUE RESECTION SYSTEM

K-Number: K103155 · 2011-10-28

ApplicantApollo Endosurgery, Inc.
Decision Date2011-10-28
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUMO ACCESS AND TISSUE RESECTION SYSTEM 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 2011-10-28 under 510(k) number K103155. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUMO ACCESS AND TISSUE RESECTION SYSTEM?

SUMO ACCESS AND TISSUE RESECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-28. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K103155.

When did SUMO ACCESS AND TISSUE RESECTION SYSTEM receive FDA 510(k) clearance?

SUMO ACCESS AND TISSUE RESECTION SYSTEM received FDA 510(k) clearance on 2011-10-28, under 510(k) number K103155.

Who is the listed applicant for SUMO ACCESS AND TISSUE RESECTION SYSTEM?

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 SUMO ACCESS AND TISSUE RESECTION SYSTEM?

The FDA product code for SUMO ACCESS AND TISSUE RESECTION SYSTEM is ODC.

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Other records listing Apollo Endosurgery, 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.

K232544Apollo ESG NXT System, Apollo REVISE NXT SystemK231553OverStitch NXT Endoscopic Suturing SystemK210266OverStitch Sx Endoscopic Suturing SystemK201808X-Tack Endoscopic HeliX Tacking SystemK171886OverStitch SX Endoscopic Suturing System (ESS)K122270OVERTUBE ENDOSCOPIC ACCESS SYSTEM

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Related Devices (Code: ODC)

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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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