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FDA 510(k)

URESIL CLOSED DRAINAGE RESERVOIR

K-Number: K863505 · 1986-09-18

ApplicantUresil Corp.
Decision Date1986-09-18
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

URESIL CLOSED DRAINAGE RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1986-09-18 under 510(k) number K863505. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL CLOSED DRAINAGE RESERVOIR?

URESIL CLOSED DRAINAGE RESERVOIR is a medical device that received FDA 510(k) clearance on 1986-09-18. The listed applicant is Uresil Corp.. The 510(k) number is K863505.

When did URESIL CLOSED DRAINAGE RESERVOIR receive FDA 510(k) clearance?

URESIL CLOSED DRAINAGE RESERVOIR received FDA 510(k) clearance on 1986-09-18, under 510(k) number K863505.

Who is the listed applicant for URESIL CLOSED DRAINAGE RESERVOIR?

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 CLOSED DRAINAGE RESERVOIR?

The FDA product code for URESIL CLOSED DRAINAGE RESERVOIR is GCY.

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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: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, 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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