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)

DISPO-URETTE

K-Number: K860796 · 1986-04-08

ApplicantRoland J. Zwick, Inc.
Decision Date1986-04-08
Product CodePCF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPO-URETTE is the device name listed in this FDA 510(k) record. The listed applicant is Roland J. Zwick, Inc.. It received FDA 510(k) clearance on 1986-04-08 under 510(k) number K860796. The device is classified under product code PCF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPO-URETTE?

DISPO-URETTE is a medical device that received FDA 510(k) clearance on 1986-04-08. The listed applicant is Roland J. Zwick, Inc.. The 510(k) number is K860796.

When did DISPO-URETTE receive FDA 510(k) clearance?

DISPO-URETTE received FDA 510(k) clearance on 1986-04-08, under 510(k) number K860796.

Who is the listed applicant for DISPO-URETTE?

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

What is the FDA product code for DISPO-URETTE?

The FDA product code for DISPO-URETTE is PCF.

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 Roland J. Zwick, 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.

K840352CIN-SHEAR

Related Devices (Code: PCF)

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.

K122658FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009Femasys, Inc.K060320FEMECC ENDOCERVICAL CURETTEFemspec LLCK882606EURO-MED ENDO-CURETTEBuckman Co., Inc.K882404KEVOR-CURETTEEuro-Med Intl.

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.

↑