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FDA 510(k)

QUIK-STITCH

K-Number: K945170 · 1995-01-18

ApplicantCoral Medical, Inc.
Decision Date1995-01-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

QUIK-STITCH is the device name listed in this FDA 510(k) record. The listed applicant is Coral Medical, Inc.. It received FDA 510(k) clearance on 1995-01-18 under 510(k) number K945170. 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 QUIK-STITCH?

QUIK-STITCH is a medical device that received FDA 510(k) clearance on 1995-01-18. The listed applicant is Coral Medical, Inc.. The 510(k) number is K945170.

When did QUIK-STITCH receive FDA 510(k) clearance?

QUIK-STITCH received FDA 510(k) clearance on 1995-01-18, under 510(k) number K945170.

Who is the listed applicant for QUIK-STITCH?

The FDA 510(k) record lists Coral Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIK-STITCH?

The FDA product code for QUIK-STITCH is GCJ.

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 Coral Medical, Inc. 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.

K953123QUIK-STITCHK944363MODEL PBD ESU PENCIL

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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