FDA 510(k)

URESIL INTRODUCING NEEDLE

K-Number: K953923 · 1995-09-08

Decision Date1995-09-08

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

URESIL INTRODUCING NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K953923. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL INTRODUCING NEEDLE?

URESIL INTRODUCING NEEDLE is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Uresil Corp.. The 510(k) number is K953923.

When did URESIL INTRODUCING NEEDLE receive FDA 510(k) clearance?

URESIL INTRODUCING NEEDLE received FDA 510(k) clearance on 1995-09-08, under 510(k) number K953923.

Who is the listed applicant for URESIL INTRODUCING NEEDLE?

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 INTRODUCING NEEDLE?

The FDA product code for URESIL INTRODUCING NEEDLE is KNW.

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Other records listing Uresil Corp. as applicant

K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE K980278URESIL VASCU-FLO INFUSION CATHETER K981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING K980282URESIL DILATOR WITH RADIOPAQUE MARKER K980889URESIL NEPHRO-URETERAL STENT K972582URESIL GUIDEWIRE

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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.