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FDA 510(k)

ENDO SMARTCAP (100501)

K-Number: K971125 · 1997-05-23

ApplicantEndo Smart Cap Co.
Decision Date1997-05-23
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO SMARTCAP (100501) is the device name listed in this FDA 510(k) record. The listed applicant is Endo Smart Cap Co.. It received FDA 510(k) clearance on 1997-05-23 under 510(k) number K971125. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO SMARTCAP (100501)?

ENDO SMARTCAP (100501) is a medical device that received FDA 510(k) clearance on 1997-05-23. The listed applicant is Endo Smart Cap Co.. The 510(k) number is K971125.

When did ENDO SMARTCAP (100501) receive FDA 510(k) clearance?

ENDO SMARTCAP (100501) received FDA 510(k) clearance on 1997-05-23, under 510(k) number K971125.

Who is the listed applicant for ENDO SMARTCAP (100501)?

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

What is the FDA product code for ENDO SMARTCAP (100501)?

The FDA product code for ENDO SMARTCAP (100501) is OCX.

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Official Source

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