FDA 510(k)

BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE

K-Number: K864402 · 1987-01-20

ApplicantNew England Surgical Instrument Corp.

Decision Date1987-01-20

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is New England Surgical Instrument Corp.. It received FDA 510(k) clearance on 1987-01-20 under 510(k) number K864402. 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 ELECTROSURGICAL INTRAOCULAR PROBE?

BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE is a medical device that received FDA 510(k) clearance on 1987-01-20. The listed applicant is New England Surgical Instrument Corp.. The 510(k) number is K864402.

When did BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE receive FDA 510(k) clearance?

BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE received FDA 510(k) clearance on 1987-01-20, under 510(k) number K864402.

Who is the listed applicant for BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE?

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

What is the FDA product code for BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE?

The FDA product code for BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE is GEI.

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Other records listing New England Surgical Instrument Corp. as applicant

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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.