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FDA 510(k)

URESIL ABSCESS DRIANAGE AND IRRIGATION SET

K-Number: K925117 · 1993-08-11

ApplicantUresil Corp.
Decision Date1993-08-11
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

URESIL ABSCESS DRIANAGE AND IRRIGATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1993-08-11 under 510(k) number K925117. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL ABSCESS DRIANAGE AND IRRIGATION SET?

URESIL ABSCESS DRIANAGE AND IRRIGATION SET is a medical device that received FDA 510(k) clearance on 1993-08-11. The listed applicant is Uresil Corp.. The 510(k) number is K925117.

When did URESIL ABSCESS DRIANAGE AND IRRIGATION SET receive FDA 510(k) clearance?

URESIL ABSCESS DRIANAGE AND IRRIGATION SET received FDA 510(k) clearance on 1993-08-11, under 510(k) number K925117.

Who is the listed applicant for URESIL ABSCESS DRIANAGE AND IRRIGATION SET?

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 ABSCESS DRIANAGE AND IRRIGATION SET?

The FDA product code for URESIL ABSCESS DRIANAGE AND IRRIGATION SET is GBX.

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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

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Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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