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FDA 510(k)

URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)

K-Number: K962652 · 1996-10-04

ApplicantCustomed, Inc.
Decision Date1996-10-04
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1996-10-04 under 510(k) number K962652. 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 URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)?

URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) is a medical device that received FDA 510(k) clearance on 1996-10-04. The listed applicant is Customed, Inc.. The 510(k) number is K962652.

When did URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) receive FDA 510(k) clearance?

URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) received FDA 510(k) clearance on 1996-10-04, under 510(k) number K962652.

Who is the listed applicant for URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)?

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

What is the FDA product code for URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)?

The FDA product code for URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) is KNX.

Related Clinical Trials

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.

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Other records listing Customed, 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962596CUSTOMED BLOOD EXTRACTION KITK961442UNIVERSAL DRAINAGE TRAYK953678STERIMED STERIZATION WRAPPER (NON-STERILE)

View all 36 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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