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FDA 510(k)

BIPOLAR TRIGGER-FLEX PROBE

K-Number: K003126 · 2001-04-11

ApplicantEllman Intl., Inc.
Decision Date2001-04-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOLAR TRIGGER-FLEX PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Intl., Inc.. It received FDA 510(k) clearance on 2001-04-11 under 510(k) number K003126. 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 BIPOLAR TRIGGER-FLEX PROBE?

BIPOLAR TRIGGER-FLEX PROBE is a medical device that received FDA 510(k) clearance on 2001-04-11. The listed applicant is Ellman Intl., Inc.. The 510(k) number is K003126.

When did BIPOLAR TRIGGER-FLEX PROBE receive FDA 510(k) clearance?

BIPOLAR TRIGGER-FLEX PROBE received FDA 510(k) clearance on 2001-04-11, under 510(k) number K003126.

Who is the listed applicant for BIPOLAR TRIGGER-FLEX PROBE?

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

What is the FDA product code for BIPOLAR TRIGGER-FLEX PROBE?

The FDA product code for BIPOLAR TRIGGER-FLEX PROBE is GEI.

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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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