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FDA 510(k)

ELECTROCAUTERY SHROUD

K-Number: K953418 · 1995-10-07

ApplicantI.C Medical, Inc.
Decision Date1995-10-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELECTROCAUTERY SHROUD is the device name listed in this FDA 510(k) record. The listed applicant is I.C Medical, Inc.. It received FDA 510(k) clearance on 1995-10-07 under 510(k) number K953418. 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 ELECTROCAUTERY SHROUD?

ELECTROCAUTERY SHROUD is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is I.C Medical, Inc.. The 510(k) number is K953418.

When did ELECTROCAUTERY SHROUD receive FDA 510(k) clearance?

ELECTROCAUTERY SHROUD received FDA 510(k) clearance on 1995-10-07, under 510(k) number K953418.

Who is the listed applicant for ELECTROCAUTERY SHROUD?

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

What is the FDA product code for ELECTROCAUTERY SHROUD?

The FDA product code for ELECTROCAUTERY SHROUD is GCJ.

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Related Devices (Code: GCJ)

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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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