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FDA 510(k)

DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)

K-Number: K062779 · 2006-10-05

ApplicantNew Wave Surgical Corporation
Decision Date2006-10-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) is the device name listed in this FDA 510(k) record. The listed applicant is New Wave Surgical Corporation. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K062779. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)?

DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is New Wave Surgical Corporation. The 510(k) number is K062779.

When did DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) receive FDA 510(k) clearance?

DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) received FDA 510(k) clearance on 2006-10-05, under 510(k) number K062779.

Who is the listed applicant for DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)?

The FDA 510(k) record lists New Wave Surgical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)?

The FDA product code for DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) is GCJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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