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FDA 510(k)

ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES

K-Number: K945254 · 1995-06-06

ApplicantEndotec, Inc.
Decision Date1995-06-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1995-06-06 under 510(k) number K945254. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES?

ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-06-06. The listed applicant is Endotec, Inc.. The 510(k) number is K945254.

When did ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES receive FDA 510(k) clearance?

ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES received FDA 510(k) clearance on 1995-06-06, under 510(k) number K945254.

Who is the listed applicant for ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES?

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

What is the FDA product code for ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES?

The FDA product code for ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES is GEI.

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Related Devices (Code: GEI)

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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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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