FDA 510(k)

DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR

K-Number: K950375 · 1995-06-14

Decision Date1995-06-14

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Boston Surgical Products, Inc.. It received FDA 510(k) clearance on 1995-06-14 under 510(k) number K950375. 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 DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR?

DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR is a medical device that received FDA 510(k) clearance on 1995-06-14. The listed applicant is Boston Surgical Products, Inc.. The 510(k) number is K950375.

When did DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR receive FDA 510(k) clearance?

DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR received FDA 510(k) clearance on 1995-06-14, under 510(k) number K950375.

Who is the listed applicant for DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR?

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

What is the FDA product code for DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR?

The FDA product code for DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR is GEI.

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Other records listing Boston Surgical Products, Inc. as applicant

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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.