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FDA 510(k)

AUTO-BAND LIGATOR

K-Number: K081142 · 2008-05-16

ApplicantScandimed International
Decision Date2008-05-16
Product CodeMND
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTO-BAND LIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Scandimed International. It received FDA 510(k) clearance on 2008-05-16 under 510(k) number K081142. 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 AUTO-BAND LIGATOR?

AUTO-BAND LIGATOR is a medical device that received FDA 510(k) clearance on 2008-05-16. The listed applicant is Scandimed International. The 510(k) number is K081142.

When did AUTO-BAND LIGATOR receive FDA 510(k) clearance?

AUTO-BAND LIGATOR received FDA 510(k) clearance on 2008-05-16, under 510(k) number K081142.

Who is the listed applicant for AUTO-BAND LIGATOR?

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

What is the FDA product code for AUTO-BAND LIGATOR?

The FDA product code for AUTO-BAND 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 Scandimed International 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.

K083556MODIFICATION TO AUTO-BAND LIGATOR

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.

K132535AUTOBAND LIGATOREndochoice, Inc.K083556MODIFICATION TO AUTO-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.

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