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)

BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR

K-Number: K851470 · 1985-06-12

ApplicantLic-Orthion
Decision Date1985-06-12
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Lic-Orthion. It received FDA 510(k) clearance on 1985-06-12 under 510(k) number K851470. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR?

BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR is a medical device that received FDA 510(k) clearance on 1985-06-12. The listed applicant is Lic-Orthion. The 510(k) number is K851470.

When did BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR receive FDA 510(k) clearance?

BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR received FDA 510(k) clearance on 1985-06-12, under 510(k) number K851470.

Who is the listed applicant for BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR?

The FDA 510(k) record lists Lic-Orthion as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR?

The FDA product code for BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR is KNX.

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 Lic-Orthion 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.

K891649PATIENT EXAMINATION GLOVES (LATEX)K862022LIC-ORTHION MULTI-THERAPY TREATMENT TABLEK854729ADAM (ABSORBENT INCONTINENCE SHIELD)K854730DAISY (ABSORBENT INCONTINENCE SHIELD)K851471TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTORK843234CITOMAT AUTOCLAVES

View all 17 devices →

Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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.

↑