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FDA 510(k)

URO-TOTE LEG BAG

K-Number: K921024 · 1992-09-02

ApplicantNeotech Products, Inc.
Decision Date1992-09-02
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URO-TOTE LEG BAG is the device name listed in this FDA 510(k) record. The listed applicant is Neotech Products, Inc.. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K921024. 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 URO-TOTE LEG BAG?

URO-TOTE LEG BAG is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Neotech Products, Inc.. The 510(k) number is K921024.

When did URO-TOTE LEG BAG receive FDA 510(k) clearance?

URO-TOTE LEG BAG received FDA 510(k) clearance on 1992-09-02, under 510(k) number K921024.

Who is the listed applicant for URO-TOTE LEG BAG?

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

What is the FDA product code for URO-TOTE LEG BAG?

The FDA product code for URO-TOTE LEG BAG is KNX.

Other records listing Neotech Products, 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.

K011564NEOLEADK931727URINARY DRAINAGE BAG CADDYK890425NEOTECH MUCUS TRAP W/CATHETERK882203NEOTECH UNIVERSAL ADAPTERK880487NEOTECH MECONIUM ASPIRATOR (STERILE)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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