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FDA 510(k)

TITAN INSUFFLATION NEEDLE

K-Number: K950243 · 1995-04-06

ApplicantEndolap, Inc.
Decision Date1995-04-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TITAN INSUFFLATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Endolap, Inc.. It received FDA 510(k) clearance on 1995-04-06 under 510(k) number K950243. 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 TITAN INSUFFLATION NEEDLE?

TITAN INSUFFLATION NEEDLE is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Endolap, Inc.. The 510(k) number is K950243.

When did TITAN INSUFFLATION NEEDLE receive FDA 510(k) clearance?

TITAN INSUFFLATION NEEDLE received FDA 510(k) clearance on 1995-04-06, under 510(k) number K950243.

Who is the listed applicant for TITAN INSUFFLATION NEEDLE?

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

What is the FDA product code for TITAN INSUFFLATION NEEDLE?

The FDA product code for TITAN INSUFFLATION NEEDLE 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 Endolap, 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.

K974516ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODEK974515ENDOLAP RESECTOSCOPE ROLLER ELECTRODEK950219ENDOLAP INSUFFLATOR TUBING SETK933492ESYS 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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