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FDA 510(k)

URESIL TRU-CLOSE DRAINAGE BAG

K-Number: K901844 · 1990-06-01

ApplicantUresil Corp.
Decision Date1990-06-01
Product CodeEXF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URESIL TRU-CLOSE DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1990-06-01 under 510(k) number K901844. The device is classified under product code EXF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL TRU-CLOSE DRAINAGE BAG?

URESIL TRU-CLOSE DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1990-06-01. The listed applicant is Uresil Corp.. The 510(k) number is K901844.

When did URESIL TRU-CLOSE DRAINAGE BAG receive FDA 510(k) clearance?

URESIL TRU-CLOSE DRAINAGE BAG received FDA 510(k) clearance on 1990-06-01, under 510(k) number K901844.

Who is the listed applicant for URESIL TRU-CLOSE DRAINAGE BAG?

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

What is the FDA product code for URESIL TRU-CLOSE DRAINAGE BAG?

The FDA product code for URESIL TRU-CLOSE DRAINAGE BAG is EXF.

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Other records listing Uresil Corp. 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.

K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHEK980278URESIL VASCU-FLO INFUSION CATHETERK981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATINGK980282URESIL DILATOR WITH RADIOPAQUE MARKERK980889URESIL NEPHRO-URETERAL STENTK972582URESIL GUIDEWIRE

View all 45 devices →

Related Devices (Code: EXF)

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.

K003078MERIT DRAINAGE DEPOTMerit Medical Systems, Inc.K990428DRAINAGE BAGRemington Medical, Inc.K980005MANAN D BAGMedical Device Technologies, Inc.K961986MANAN D BAGManan Medical Products, Inc.K963849MANAN D BAGManan Medical Products, Inc.K943663NAVARRE 600 ML DRAINAGE BAGNavarre Biomedical , Ltd.

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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