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FDA 510(k)

OPHTEC ENCLAVATION NEEDLE

K-Number: K030471 · 2003-04-17

ApplicantOphtec, USA
Decision Date2003-04-17
Product CodeHNQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTEC ENCLAVATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Ophtec, USA. It received FDA 510(k) clearance on 2003-04-17 under 510(k) number K030471. The device is classified under product code HNQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTEC ENCLAVATION NEEDLE?

OPHTEC ENCLAVATION NEEDLE is a medical device that received FDA 510(k) clearance on 2003-04-17. The listed applicant is Ophtec, USA. The 510(k) number is K030471.

When did OPHTEC ENCLAVATION NEEDLE receive FDA 510(k) clearance?

OPHTEC ENCLAVATION NEEDLE received FDA 510(k) clearance on 2003-04-17, under 510(k) number K030471.

Who is the listed applicant for OPHTEC ENCLAVATION NEEDLE?

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

What is the FDA product code for OPHTEC ENCLAVATION NEEDLE?

The FDA product code for OPHTEC ENCLAVATION NEEDLE is HNQ.

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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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