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FDA 510(k)

CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE

K-Number: K971937 · 1997-08-15

ApplicantTerumo Medical Corp.
Decision Date1997-08-15
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K971937. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE?

CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Terumo Medical Corp.. The 510(k) number is K971937.

When did CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE receive FDA 510(k) clearance?

CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE received FDA 510(k) clearance on 1997-08-15, under 510(k) number K971937.

Who is the listed applicant for CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE?

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

What is the FDA product code for CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE?

The FDA product code for CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE is OCY.

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Other records listing Terumo Medical 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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Related Devices (Code: OCY)

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.

K153264EasyPass GuidewireMedi-Globe CorporationK131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/SK124052OSTAVI HYDROPHILIC GUIDEWIRELake Region MedicalK123438XENX STONE MANAGEMENT DEVICEXenolith MedicalK123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, 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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