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FDA 510(k)

DISPOSABLE URINE GAB-70.XX

K-Number: K812251 · 1981-08-20

ApplicantManfred Sauer Corp.
Decision Date1981-08-20
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE URINE GAB-70.XX is the device name listed in this FDA 510(k) record. The listed applicant is Manfred Sauer Corp.. It received FDA 510(k) clearance on 1981-08-20 under 510(k) number K812251. 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 DISPOSABLE URINE GAB-70.XX?

DISPOSABLE URINE GAB-70.XX is a medical device that received FDA 510(k) clearance on 1981-08-20. The listed applicant is Manfred Sauer Corp.. The 510(k) number is K812251.

When did DISPOSABLE URINE GAB-70.XX receive FDA 510(k) clearance?

DISPOSABLE URINE GAB-70.XX received FDA 510(k) clearance on 1981-08-20, under 510(k) number K812251.

Who is the listed applicant for DISPOSABLE URINE GAB-70.XX?

The FDA 510(k) record lists Manfred Sauer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE URINE GAB-70.XX?

The FDA product code for DISPOSABLE URINE GAB-70.XX 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 Manfred Sauer Corp. 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.

K812249SKIN ADHESIVE-50XXK812250CONDOM-52.XXK812252LATEX LEG BAG-57.XX

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.

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