Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SRS ENDOSCOPIC STAPLING SYSTEM

K-Number: K120299 · 2012-05-18

ApplicantMedigus , Ltd.
Decision Date2012-05-18
Product CodeODE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SRS ENDOSCOPIC STAPLING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medigus , Ltd.. It received FDA 510(k) clearance on 2012-05-18 under 510(k) number K120299. 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 SRS ENDOSCOPIC STAPLING SYSTEM?

SRS ENDOSCOPIC STAPLING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-18. The listed applicant is Medigus , Ltd.. The 510(k) number is K120299.

When did SRS ENDOSCOPIC STAPLING SYSTEM receive FDA 510(k) clearance?

SRS ENDOSCOPIC STAPLING SYSTEM received FDA 510(k) clearance on 2012-05-18, under 510(k) number K120299.

Who is the listed applicant for SRS ENDOSCOPIC STAPLING SYSTEM?

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

What is the FDA product code for SRS ENDOSCOPIC STAPLING SYSTEM?

The FDA product code for SRS ENDOSCOPIC STAPLING SYSTEM 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

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.K092400ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5Endogastric Solutions, Inc.

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.

↑