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FDA 510(k)

ENDOSPOT

K-Number: K963043 · 1996-09-20

ApplicantCorin USA
Decision Date1996-09-20
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSPOT is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 1996-09-20 under 510(k) number K963043. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSPOT?

ENDOSPOT is a medical device that received FDA 510(k) clearance on 1996-09-20. The listed applicant is Corin USA. The 510(k) number is K963043.

When did ENDOSPOT receive FDA 510(k) clearance?

ENDOSPOT received FDA 510(k) clearance on 1996-09-20, under 510(k) number K963043.

Who is the listed applicant for ENDOSPOT?

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

What is the FDA product code for ENDOSPOT?

The FDA product code for ENDOSPOT is FCW.

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Other records listing Corin USA 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.

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Related Devices (Code: FCW)

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.

K123956POWER LED 175KARL STORZ Endoscopy-America, Inc.K123359OVS1 VIDEO SYSTEMOlive Medical Corp.K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.K093792LED LIGHT SOURCESunoptic Technologies, LLCK091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ Endoscopy-America, Inc.K082813STRYKER LED LIGHTSOURCEStryker Corp.

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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