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FDA 510(k)

URETHRAL CATH. TRAY W/BAG

K-Number: K840292 · 1984-03-16

ApplicantCorpak Co.
Decision Date1984-03-16
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETHRAL CATH. TRAY W/BAG is the device name listed in this FDA 510(k) record. The listed applicant is Corpak Co.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K840292. 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 URETHRAL CATH. TRAY W/BAG?

URETHRAL CATH. TRAY W/BAG is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Corpak Co.. The 510(k) number is K840292.

When did URETHRAL CATH. TRAY W/BAG receive FDA 510(k) clearance?

URETHRAL CATH. TRAY W/BAG received FDA 510(k) clearance on 1984-03-16, under 510(k) number K840292.

Who is the listed applicant for URETHRAL CATH. TRAY W/BAG?

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

What is the FDA product code for URETHRAL CATH. TRAY W/BAG?

The FDA product code for URETHRAL CATH. TRAY W/BAG is KNX.

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Other records listing Corpak Co. 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.

K935512CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACOREK931921CORPAK GASTROSTOMY TUBEK932847CORPAK ENTERAL PUMPK902949CORPAK GRASPING FORCEPSK901501CORPAK GASTROSTOMY TUBEK882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE

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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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