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FDA 510(k)

BAG, DISPOSABLE URINARY LEG

K-Number: K760260 · 1976-10-20

ApplicantIntermed, Inc.
Decision Date1976-10-20
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAG, DISPOSABLE URINARY LEG is the device name listed in this FDA 510(k) record. The listed applicant is Intermed, Inc.. It received FDA 510(k) clearance on 1976-10-20 under 510(k) number K760260. 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 BAG, DISPOSABLE URINARY LEG?

BAG, DISPOSABLE URINARY LEG is a medical device that received FDA 510(k) clearance on 1976-10-20. The listed applicant is Intermed, Inc.. The 510(k) number is K760260.

When did BAG, DISPOSABLE URINARY LEG receive FDA 510(k) clearance?

BAG, DISPOSABLE URINARY LEG received FDA 510(k) clearance on 1976-10-20, under 510(k) number K760260.

Who is the listed applicant for BAG, DISPOSABLE URINARY LEG?

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

What is the FDA product code for BAG, DISPOSABLE URINARY LEG?

The FDA product code for BAG, DISPOSABLE URINARY LEG is KNX.

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Other records listing Intermed, 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.

K900857NON STERILE PARENTERAL SUPPLY KITK842166INTERMED, INS STERILE WATER/SALINEK833126DRESSING CHANGE TRAYSK833574PERCUTANEOUS SHEATH INTRODUCER TRAYSK833573CENTRAL VEIN CATH. TRAY CC-20-1420K833139ACUTE HEMODIALYSIS TRAYS

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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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