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FDA 510(k)

KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER

K-Number: K931459 · 1993-06-14

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1993-06-14
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. It received FDA 510(k) clearance on 1993-06-14 under 510(k) number K931459. 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 KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER?

KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER is a medical device that received FDA 510(k) clearance on 1993-06-14. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K931459.

When did KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER receive FDA 510(k) clearance?

KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER received FDA 510(k) clearance on 1993-06-14, under 510(k) number K931459.

Who is the listed applicant for KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER?

The FDA 510(k) record lists Kendall Healthcare Products Co. Div.Of Tyco Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER?

The FDA product code for KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER is KNX.

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Other records listing Kendall Healthcare Products Co. Div.Of Tyco Health 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.

K973763KENDALL CURITY IODOFORM PACKING STRIPK973511KENDALL CURITY PETROLATUM GAUZEK973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)K973619KENDALL CURITY NON-ADHERING DRESSINGK973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSINGK973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

View all 66 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.

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