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FDA 510(k)

INTRACULA II

K-Number: K800099 · 1980-02-21

ApplicantKt Medical, Inc.
Decision Date1980-02-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRACULA II is the device name listed in this FDA 510(k) record. The listed applicant is Kt Medical, Inc.. It received FDA 510(k) clearance on 1980-02-21 under 510(k) number K800099. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRACULA II?

INTRACULA II is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Kt Medical, Inc.. The 510(k) number is K800099.

When did INTRACULA II receive FDA 510(k) clearance?

INTRACULA II received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800099.

Who is the listed applicant for INTRACULA II?

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

What is the FDA product code for INTRACULA II?

The FDA product code for INTRACULA II is IYO.

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Other records listing Kt Medical, Inc. 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.

K800653SINVISION LINEAR ARRAY REAL TIMEK800652MODEL E03 ECHO-OPTHALMOSCOPEK8001014200 ME ECHOENCEPHALOGRAPHK800092COMBISON COMPUTERK8001007200 MA ECHO-OPHTHALMOSCOPEK800093TRANSDUCER

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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