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FDA 510(k)

INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER

K-Number: K950277 · 1995-03-29

ApplicantBoston Scientific Corp
Decision Date1995-03-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1995-03-29 under 510(k) number K950277. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER?

INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER is a medical device that received FDA 510(k) clearance on 1995-03-29. The listed applicant is Boston Scientific Corp. The 510(k) number is K950277.

When did INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER receive FDA 510(k) clearance?

INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER received FDA 510(k) clearance on 1995-03-29, under 510(k) number K950277.

Who is the listed applicant for INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER?

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

What is the FDA product code for INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER?

The FDA product code for INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER is GCJ.

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Related Devices (Code: GCJ)

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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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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