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FDA 510(k)

TROCAR GRASPER/ANVIL APPROXIMATOR

K-Number: K921336 · 1992-11-06

ApplicantEndoscopic Surgical Products, Inc.
Decision Date1992-11-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TROCAR GRASPER/ANVIL APPROXIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Surgical Products, Inc.. It received FDA 510(k) clearance on 1992-11-06 under 510(k) number K921336. 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 TROCAR GRASPER/ANVIL APPROXIMATOR?

TROCAR GRASPER/ANVIL APPROXIMATOR is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Endoscopic Surgical Products, Inc.. The 510(k) number is K921336.

When did TROCAR GRASPER/ANVIL APPROXIMATOR receive FDA 510(k) clearance?

TROCAR GRASPER/ANVIL APPROXIMATOR received FDA 510(k) clearance on 1992-11-06, under 510(k) number K921336.

Who is the listed applicant for TROCAR GRASPER/ANVIL APPROXIMATOR?

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

What is the FDA product code for TROCAR GRASPER/ANVIL APPROXIMATOR?

The FDA product code for TROCAR GRASPER/ANVIL APPROXIMATOR 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 Surgical Products, 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.

K921335ULTRAFLOW SUCTION-IRRIGATION CANNULA

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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