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FDA 510(k)

ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES

K-Number: K944642 · 1994-12-08

ApplicantBoston Surgical Products, Inc.
Decision Date1994-12-08
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 Boston Surgical Products, Inc.. It received FDA 510(k) clearance on 1994-12-08 under 510(k) number K944642. 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 1994-12-08. The listed applicant is Boston Surgical Products, Inc.. The 510(k) number is K944642.

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

ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES received FDA 510(k) clearance on 1994-12-08, under 510(k) number K944642.

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

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 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES?

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

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Other records listing Boston Surgical Products, Inc. as applicant

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.

K972311MODEL 20 BIPOLAR COAGULATORK972350MODEL 50 BIPOLAR COAGULATORK944947ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSK950375DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATORK951912DISOPOSABLE & RESUABLE MONPOLAR CORD

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Related Devices (Code: 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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