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FDA 510(k)

STORC INTRAUTERINE PRESSURE CATHETER

K-Number: K954955 · 1996-04-17

ApplicantClinical Innovations, Inc.
Decision Date1996-04-17
Product CodeHFN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

STORC INTRAUTERINE PRESSURE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, Inc.. It received FDA 510(k) clearance on 1996-04-17 under 510(k) number K954955. The device is classified under product code HFN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STORC INTRAUTERINE PRESSURE CATHETER?

STORC INTRAUTERINE PRESSURE CATHETER is a medical device that received FDA 510(k) clearance on 1996-04-17. The listed applicant is Clinical Innovations, Inc.. The 510(k) number is K954955.

When did STORC INTRAUTERINE PRESSURE CATHETER receive FDA 510(k) clearance?

STORC INTRAUTERINE PRESSURE CATHETER received FDA 510(k) clearance on 1996-04-17, under 510(k) number K954955.

Who is the listed applicant for STORC INTRAUTERINE PRESSURE CATHETER?

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

What is the FDA product code for STORC INTRAUTERINE PRESSURE CATHETER?

The FDA product code for STORC INTRAUTERINE PRESSURE CATHETER is HFN.

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 Clinical Innovations, 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.

K030691FETAL SPIRAL ELECTRODE, MODEL FSE07000K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000K981260KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MK974563COLPO CUP CVC-2000K974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER

View all 9 devices →

Related Devices (Code: HFN)

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.

K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLCK974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.K973746PRE-FILLED SYRINGE FOR KOALA IUPClinical Innovations, Inc.K961424INTRAN 500Utah Medical Products, Inc.K955443INTRAN PLUSUtah Medical Products, Inc.K920375DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERTelos Medical Corp.

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.

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