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FDA 510(k)

BIPOLAR CARD

K-Number: K831236 · 1983-06-02

ApplicantNew England Surgical Instrument Corp.
Decision Date1983-06-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOLAR CARD 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 1983-06-02 under 510(k) number K831236. 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 CARD?

BIPOLAR CARD is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is New England Surgical Instrument Corp.. The 510(k) number is K831236.

When did BIPOLAR CARD receive FDA 510(k) clearance?

BIPOLAR CARD received FDA 510(k) clearance on 1983-06-02, under 510(k) number K831236.

Who is the listed applicant for BIPOLAR CARD?

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 CARD?

The FDA product code for BIPOLAR CARD is GEI.

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Other records listing New England Surgical Instrument Corp. 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.

K895331ELECTROSURGICAL ELECTRODEK895337ELECTROSURGICAL COAGULATION SUCTION TUBEK883963RANEY AND LEROY-RANEY SCALP CLIPK883396HANDSWITCHING MONOPOLAR PENCILK880863BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200K880859SURGICAL BURS

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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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