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FDA 510(k)

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR

K-Number: K071553 · 2007-09-18

ApplicantNdo Surgical, Inc.
Decision Date2007-09-18
Product CodeODE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ndo Surgical, Inc.. It received FDA 510(k) clearance on 2007-09-18 under 510(k) number K071553. The device is classified under product code ODE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR?

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR is a medical device that received FDA 510(k) clearance on 2007-09-18. The listed applicant is Ndo Surgical, Inc.. The 510(k) number is K071553.

When did ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR receive FDA 510(k) clearance?

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR received FDA 510(k) clearance on 2007-09-18, under 510(k) number K071553.

Who is the listed applicant for ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR?

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

What is the FDA product code for ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR?

The FDA product code for ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR is ODE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ndo Surgical, 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.

K073671PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGEK072125ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENTK032820MODIFICATION TO ENDOSCOPIC PLICATION SYSTEMK031262ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760K023234ENDOSCOPIC PLICATION SYSTEM

Related Devices (Code: ODE)

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.

K233240GERDX-SystemG-Surg GmbHK240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.K120299SRS ENDOSCOPIC STAPLING SYSTEMMedigus , Ltd.

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.

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