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FDA 510(k)

SABRE ULTIMATE SHIELDED TROCAR

K-Number: K943976 · 1994-09-07

ApplicantEndoscopic Concepts, Inc.
Decision Date1994-09-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SABRE ULTIMATE SHIELDED TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Concepts, Inc.. It received FDA 510(k) clearance on 1994-09-07 under 510(k) number K943976. 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 SABRE ULTIMATE SHIELDED TROCAR?

SABRE ULTIMATE SHIELDED TROCAR is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Endoscopic Concepts, Inc.. The 510(k) number is K943976.

When did SABRE ULTIMATE SHIELDED TROCAR receive FDA 510(k) clearance?

SABRE ULTIMATE SHIELDED TROCAR received FDA 510(k) clearance on 1994-09-07, under 510(k) number K943976.

Who is the listed applicant for SABRE ULTIMATE SHIELDED TROCAR?

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

What is the FDA product code for SABRE ULTIMATE SHIELDED TROCAR?

The FDA product code for SABRE ULTIMATE SHIELDED TROCAR 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 Endoscopic Concepts, 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.

K980804SABRE BT BLUNT0TIP SURGICAL TROCARK952977SABRE MULTI-USE TROCAR SYSTEMK950500BASIC REUSABLE TROCAR SYSTEM

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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