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)

ACCESS POINT

K-Number: K953376 · 1995-09-12

ApplicantAccess Surgical Intl., Inc.
Decision Date1995-09-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACCESS POINT 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 1995-09-12 under 510(k) number K953376. 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 ACCESS POINT?

ACCESS POINT is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Access Surgical Intl., Inc.. The 510(k) number is K953376.

When did ACCESS POINT receive FDA 510(k) clearance?

ACCESS POINT received FDA 510(k) clearance on 1995-09-12, under 510(k) number K953376.

Who is the listed applicant for ACCESS POINT?

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 ACCESS POINT?

The FDA product code for ACCESS POINT 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 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, HANDELK945545ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTSK944974ACCESS POINTK940587FLEX-I-PORTK933192ACCESS 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

View on FDA Database →

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

↑