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FDA 510(k)

VANGUARD REPROCESSED SUTURE PASSER

K-Number: K053585 · 2006-10-11

ApplicantAscent Healthcare Solutions
Decision Date2006-10-11
Product CodeNLM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VANGUARD REPROCESSED SUTURE PASSER is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Healthcare Solutions. It received FDA 510(k) clearance on 2006-10-11 under 510(k) number K053585. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANGUARD REPROCESSED SUTURE PASSER?

VANGUARD REPROCESSED SUTURE PASSER is a medical device that received FDA 510(k) clearance on 2006-10-11. The listed applicant is Ascent Healthcare Solutions. The 510(k) number is K053585.

When did VANGUARD REPROCESSED SUTURE PASSER receive FDA 510(k) clearance?

VANGUARD REPROCESSED SUTURE PASSER received FDA 510(k) clearance on 2006-10-11, under 510(k) number K053585.

Who is the listed applicant for VANGUARD REPROCESSED SUTURE PASSER?

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

What is the FDA product code for VANGUARD REPROCESSED SUTURE PASSER?

The FDA product code for VANGUARD REPROCESSED SUTURE PASSER is NLM.

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Other records listing Ascent Healthcare Solutions 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.

K111600REPROCESSED HAND ACTIVATE SEALER/DIVIDERK110189REPROCESSED ELECTROSURGICAL INSTRUMENTK100909REPROCESSED COMPRESSION SLEEVESK100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERK100537REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUEK100080REPROCESSED TROCARS, MODEL B5LT AND CB5LT

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Related Devices (Code: NLM)

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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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