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FDA 510(k)

STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES

K-Number: K913223 · 1991-09-04

ApplicantMedical Device Inspection Co., Inc.
Decision Date1991-09-04
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Inspection Co., Inc.. It received FDA 510(k) clearance on 1991-09-04 under 510(k) number K913223. 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 STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES?

STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1991-09-04. The listed applicant is Medical Device Inspection Co., Inc.. The 510(k) number is K913223.

When did STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES receive FDA 510(k) clearance?

STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES received FDA 510(k) clearance on 1991-09-04, under 510(k) number K913223.

Who is the listed applicant for STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES?

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

What is the FDA product code for STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES?

The FDA product code for STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES is KNX.

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Other records listing Medical Device Inspection Co., 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.

K945826J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONSK932072JARIT SURGICAL INSTRUMENTSK931594THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEMK933580POWER WORK TABLEK933578POWERMATIC MAT PLATFORMK933581POWERMATIC TREATMENT TABLE

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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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