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FDA 510(k)

GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER

K-Number: K881213 · 1988-07-28

ApplicantGeneva Laboratories, Inc.
Decision Date1988-07-28
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER is the device name listed in this FDA 510(k) record. The listed applicant is Geneva Laboratories, Inc.. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K881213. 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 GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER?

GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Geneva Laboratories, Inc.. The 510(k) number is K881213.

When did GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER receive FDA 510(k) clearance?

GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER received FDA 510(k) clearance on 1988-07-28, under 510(k) number K881213.

Who is the listed applicant for GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER?

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

What is the FDA product code for GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER?

The FDA product code for GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER is KNX.

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Other records listing Geneva Laboratories, 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.

K881217GENT-L-KARE STERILE URINARY LEG BAGK881218GENT-L-KARE CLEANSING ENEMA SETK881216GENT-L-KARE VAGINAL IRRIGATION SETK861308ACCUPAC CUSTOM PACK KERLIX SQUARESK861219ACCUPAC CUSTOM SKIN SCRUB KITK853265ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543

View all 13 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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