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FDA 510(k)

FEMALE EXTERNAL URINARY COLLECTION POUCH

K-Number: K971499 · 1997-08-28

ApplicantMediquest, Inc.
Decision Date1997-08-28
Product CodeEXI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FEMALE EXTERNAL URINARY COLLECTION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Mediquest, Inc.. It received FDA 510(k) clearance on 1997-08-28 under 510(k) number K971499. The device is classified under product code EXI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMALE EXTERNAL URINARY COLLECTION POUCH?

FEMALE EXTERNAL URINARY COLLECTION POUCH is a medical device that received FDA 510(k) clearance on 1997-08-28. The listed applicant is Mediquest, Inc.. The 510(k) number is K971499.

When did FEMALE EXTERNAL URINARY COLLECTION POUCH receive FDA 510(k) clearance?

FEMALE EXTERNAL URINARY COLLECTION POUCH received FDA 510(k) clearance on 1997-08-28, under 510(k) number K971499.

Who is the listed applicant for FEMALE EXTERNAL URINARY COLLECTION POUCH?

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

What is the FDA product code for FEMALE EXTERNAL URINARY COLLECTION POUCH?

The FDA product code for FEMALE EXTERNAL URINARY COLLECTION POUCH is EXI.

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 Mediquest, 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.

K840089SKIN STAPLE REMOVER

Related Devices (Code: EXI)

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.

K970443HOLLISTER RETRACTED PENIS POUCHHollister, Inc.K963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEBioderm, Inc.K931277HOLLISTER PREMIUM URINE COLLECTORHollister, Inc.K924755CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTIONConvatec, A Division of E.R. Squibb & SonsK915246CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)Coloplast A/SK915616URIHESIVE STRIPConvatec, A Division of E.R. Squibb & Sons

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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