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FDA 510(k)

URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

K-Number: K915343 · 1992-03-31

ApplicantUresil Corp.
Decision Date1992-03-31
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1992-03-31 under 510(k) number K915343. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER?

URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER is a medical device that received FDA 510(k) clearance on 1992-03-31. The listed applicant is Uresil Corp.. The 510(k) number is K915343.

When did URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER receive FDA 510(k) clearance?

URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER received FDA 510(k) clearance on 1992-03-31, under 510(k) number K915343.

Who is the listed applicant for URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER?

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 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER?

The FDA product code for URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER is GCA.

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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: GCA)

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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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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