Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DISPOSABLE SURGICAL TROCAR WITH SEAL

K-Number: K911589 · 1991-07-05

ApplicantApplied Vascular Devices, Inc.
Decision Date1991-07-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SURGICAL TROCAR WITH SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Applied Vascular Devices, Inc.. It received FDA 510(k) clearance on 1991-07-05 under 510(k) number K911589. 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 DISPOSABLE SURGICAL TROCAR WITH SEAL?

DISPOSABLE SURGICAL TROCAR WITH SEAL is a medical device that received FDA 510(k) clearance on 1991-07-05. The listed applicant is Applied Vascular Devices, Inc.. The 510(k) number is K911589.

When did DISPOSABLE SURGICAL TROCAR WITH SEAL receive FDA 510(k) clearance?

DISPOSABLE SURGICAL TROCAR WITH SEAL received FDA 510(k) clearance on 1991-07-05, under 510(k) number K911589.

Who is the listed applicant for DISPOSABLE SURGICAL TROCAR WITH SEAL?

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

What is the FDA product code for DISPOSABLE SURGICAL TROCAR WITH SEAL?

The FDA product code for DISPOSABLE SURGICAL TROCAR WITH SEAL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Applied Vascular Devices, 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.

K911730SURGICAL OBTURATOR WITH SEALK910339AVD INTIMAX OCCLUSION CATHETERK910372INTIMAX THROMBECTOMY CATHETERK911181INTIMAX(TM) IRRIGATION CATHETERK910493AVD INTIMAX CHOLANGIOGRAPHY CATHETERK903848DIAGNOSTIC INTRASCULAR CATHETER

View all 21 devices →

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.

↑