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FDA 510(k)

IUP - TIP TRANS, IUP - PROXI TRANS

K-Number: K961290 · 1996-10-15

ApplicantScientific Device Manufacturer, LLC
Decision Date1996-10-15
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IUP - TIP TRANS, IUP - PROXI TRANS is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Device Manufacturer, LLC. It received FDA 510(k) clearance on 1996-10-15 under 510(k) number K961290. The device is classified under product code KXO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IUP - TIP TRANS, IUP - PROXI TRANS?

IUP - TIP TRANS, IUP - PROXI TRANS is a medical device that received FDA 510(k) clearance on 1996-10-15. The listed applicant is Scientific Device Manufacturer, LLC. The 510(k) number is K961290.

When did IUP - TIP TRANS, IUP - PROXI TRANS receive FDA 510(k) clearance?

IUP - TIP TRANS, IUP - PROXI TRANS received FDA 510(k) clearance on 1996-10-15, under 510(k) number K961290.

Who is the listed applicant for IUP - TIP TRANS, IUP - PROXI TRANS?

The FDA 510(k) record lists Scientific Device Manufacturer, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IUP - TIP TRANS, IUP - PROXI TRANS?

The FDA product code for IUP - TIP TRANS, IUP - PROXI TRANS is KXO.

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 Scientific Device Manufacturer, LLC 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.

K960764SAFE-CATHK960431PRESSURE STOPCOCK/MANIFOLDK960430CONTROL SYRINGEK960917PERCUGLIDEK952579TOCO TRANSDUCER

Related Devices (Code: KXO)

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.

K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)Ludlow Technical ProductsK982565EASY TRANS TIPCarl SchuhK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)Graphic Controls Corp.K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)Graphic Controls Corp.K950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls Corp.K950708LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000Graphic Controls Corp.

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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