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)

AUTOBAND LIGATOR

K-Number: K132535 · 2013-08-23

ApplicantEndochoice, Inc.
Decision Date2013-08-23
Product CodeMND
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTOBAND LIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2013-08-23 under 510(k) number K132535. The device is classified under product code MND. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOBAND LIGATOR?

AUTOBAND LIGATOR is a medical device that received FDA 510(k) clearance on 2013-08-23. The listed applicant is Endochoice, Inc.. The 510(k) number is K132535.

When did AUTOBAND LIGATOR receive FDA 510(k) clearance?

AUTOBAND LIGATOR received FDA 510(k) clearance on 2013-08-23, under 510(k) number K132535.

Who is the listed applicant for AUTOBAND LIGATOR?

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

What is the FDA product code for AUTOBAND LIGATOR?

The FDA product code for AUTOBAND LIGATOR is MND.

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 Endochoice, 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.

K160275Fuse Endoscopic System with FuseBox ProcessorK161482EndoChoice Water Bottle Cap Irrigation SystemK161167Seal Single-Use Biopsy ValveK160403SmartStart Air/Water and Suction ValvesK153588EndoChoice Water Bottle Cap SystemK151475EndoChoice Select Injection Needle

View all 17 devices →

Related Devices (Code: MND)

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.

K083556MODIFICATION TO AUTO-BAND LIGATORScandimed InternationalK081142AUTO-BAND LIGATORScandimed InternationalK051950INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321Ethicon Endo-Surgery, Inc.K031236AUTO-BAND LIGATORScandimed. A.S.K033245BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700UC.R. Bard, Inc.K022434BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700UC.R. Bard, 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.

↑