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FDA 510(k)

HYDROPHILIC COATED GUIDEWIRE

K-Number: K926344 · 1993-03-05

ApplicantSurgitek
Decision Date1993-03-05
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HYDROPHILIC COATED GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Surgitek. It received FDA 510(k) clearance on 1993-03-05 under 510(k) number K926344. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROPHILIC COATED GUIDEWIRE?

HYDROPHILIC COATED GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1993-03-05. The listed applicant is Surgitek. The 510(k) number is K926344.

When did HYDROPHILIC COATED GUIDEWIRE receive FDA 510(k) clearance?

HYDROPHILIC COATED GUIDEWIRE received FDA 510(k) clearance on 1993-03-05, under 510(k) number K926344.

Who is the listed applicant for HYDROPHILIC COATED GUIDEWIRE?

The FDA 510(k) record lists Surgitek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROPHILIC COATED GUIDEWIRE?

The FDA product code for HYDROPHILIC COATED GUIDEWIRE is KNY.

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Other records listing Surgitek 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.

K946296QUADRA-COIL URETERAL STENTK944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMK943491RIGHT ANGLE UROLOGIC LASER FIBERK941952SURGITEK INFUSERK933260HELICAL STONE/FLATWIRE STONE BASKETSK933261GRASPING FORCEPS

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Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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