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FDA 510(k)

MODIFICATION TO AUTO-BAND LIGATOR

K-Number: K083556 · 2009-02-19

ApplicantScandimed International
Decision Date2009-02-19
Product CodeMND
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2009-02-19 under 510(k) number K083556. 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 MODIFICATION TO AUTO-BAND LIGATOR?

MODIFICATION TO AUTO-BAND LIGATOR is a medical device that received FDA 510(k) clearance on 2009-02-19. The listed applicant is Scandimed International. The 510(k) number is K083556.

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

MODIFICATION TO AUTO-BAND LIGATOR received FDA 510(k) clearance on 2009-02-19, under 510(k) number K083556.

Who is the listed applicant for MODIFICATION TO 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 MODIFICATION TO AUTO-BAND LIGATOR?

The FDA product code for MODIFICATION TO 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.

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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.

K081142AUTO-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.K081142AUTO-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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