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FDA 510(k)

INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES

K-Number: K944672 · 1994-12-06

ApplicantBoston Scientific Corp
Decision Date1994-12-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES 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 1994-12-06 under 510(k) number K944672. 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 NEEDLE DRIVER SUTURING DEVICES?

INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES is a medical device that received FDA 510(k) clearance on 1994-12-06. The listed applicant is Boston Scientific Corp. The 510(k) number is K944672.

When did INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES receive FDA 510(k) clearance?

INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES received FDA 510(k) clearance on 1994-12-06, under 510(k) number K944672.

Who is the listed applicant for INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES?

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 NEEDLE DRIVER SUTURING DEVICES?

The FDA product code for INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES is GCJ.

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Other records listing Boston Scientific Corp as applicant

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K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)K231328LUX-Dx II (M302); LUX-Dx II+ (M312)K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSK133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMK131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESK131914OFFROAD RE-ENTRY CATHETER SYSTEM

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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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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