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FDA 510(k)

FLEX-I-PORT

K-Number: K940587 · 1994-03-29

ApplicantAccess Surgical Intl., Inc.
Decision Date1994-03-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEX-I-PORT is the device name listed in this FDA 510(k) record. The listed applicant is Access Surgical Intl., Inc.. It received FDA 510(k) clearance on 1994-03-29 under 510(k) number K940587. 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 FLEX-I-PORT?

FLEX-I-PORT is a medical device that received FDA 510(k) clearance on 1994-03-29. The listed applicant is Access Surgical Intl., Inc.. The 510(k) number is K940587.

When did FLEX-I-PORT receive FDA 510(k) clearance?

FLEX-I-PORT received FDA 510(k) clearance on 1994-03-29, under 510(k) number K940587.

Who is the listed applicant for FLEX-I-PORT?

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

What is the FDA product code for FLEX-I-PORT?

The FDA product code for FLEX-I-PORT is GCJ.

Other records listing Access Surgical Intl., 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.

K954536BLADE, SCALPEL & BLADE, HANDELK953376ACCESS POINTK945545ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTSK944974ACCESS POINTK933192ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.K922424ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM.

View all 9 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

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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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