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FDA 510(k)

URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA

K-Number: K863560 · 1986-09-29

ApplicantUresil Corp.
Decision Date1986-09-29
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1986-09-29 under 510(k) number K863560. The device is classified under product code GBS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA?

URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA is a medical device that received FDA 510(k) clearance on 1986-09-29. The listed applicant is Uresil Corp.. The 510(k) number is K863560.

When did URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA receive FDA 510(k) clearance?

URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA received FDA 510(k) clearance on 1986-09-29, under 510(k) number K863560.

Who is the listed applicant for URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA?

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 STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA?

The FDA product code for URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA is GBS.

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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: GBS)

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.

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.K883887AXIOM ATRAUM WOUND DRAINSAxiom, Inc.K881873INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.K880895URESIL WOUND DRAIN TROCARUresil Corp.K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, 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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