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)

ENDOBUTTON CONTINUOUS LOOP (CL)

K-Number: K081098 · 2008-07-16

ApplicantSmith & Nephew Inc., Endoscopy Division
Decision Date2008-07-16
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOBUTTON CONTINUOUS LOOP (CL) is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Division. It received FDA 510(k) clearance on 2008-07-16 under 510(k) number K081098. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOBUTTON CONTINUOUS LOOP (CL)?

ENDOBUTTON CONTINUOUS LOOP (CL) is a medical device that received FDA 510(k) clearance on 2008-07-16. The listed applicant is Smith & Nephew Inc., Endoscopy Division. The 510(k) number is K081098.

When did ENDOBUTTON CONTINUOUS LOOP (CL) receive FDA 510(k) clearance?

ENDOBUTTON CONTINUOUS LOOP (CL) received FDA 510(k) clearance on 2008-07-16, under 510(k) number K081098.

Who is the listed applicant for ENDOBUTTON CONTINUOUS LOOP (CL)?

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

What is the FDA product code for ENDOBUTTON CONTINUOUS LOOP (CL)?

The FDA product code for ENDOBUTTON CONTINUOUS LOOP (CL) is JDR.

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 Smith & Nephew Inc., Endoscopy Division 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.

K121904GYNECOLOGY STERILIZATION TRAYK102982ENDOBUTTON DIRECTK082215OSTEORAPTOR SUTURE ANCHORK072785TWINFIX FT PKK071586BIORAPTOR 2.3 PK SUTURE ANCHORK070908SMITH & NEPHEW KINSA RC SUTURE ANCHOR

View all 8 devices →

Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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.

↑