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FDA 510(k)

BALL TIP COAGULATING ELECTRODES

K-Number: K822062 · 1982-08-19

ApplicantAmerican Endoscopy, Inc.
Decision Date1982-08-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BALL TIP COAGULATING ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is American Endoscopy, Inc.. It received FDA 510(k) clearance on 1982-08-19 under 510(k) number K822062. 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 BALL TIP COAGULATING ELECTRODES?

BALL TIP COAGULATING ELECTRODES is a medical device that received FDA 510(k) clearance on 1982-08-19. The listed applicant is American Endoscopy, Inc.. The 510(k) number is K822062.

When did BALL TIP COAGULATING ELECTRODES receive FDA 510(k) clearance?

BALL TIP COAGULATING ELECTRODES received FDA 510(k) clearance on 1982-08-19, under 510(k) number K822062.

Who is the listed applicant for BALL TIP COAGULATING ELECTRODES?

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

What is the FDA product code for BALL TIP COAGULATING ELECTRODES?

The FDA product code for BALL TIP COAGULATING ELECTRODES is GEI.

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Other records listing American Endoscopy, 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.

K853274AMERICAN DILATATION SYSTEMK841384PROXIMA 1 PH MONITORK833491ENDO BITE BLOCKK840818BIOPSY FORCEPSK833859TAMPONADE BALLOON CUFFK833492PERCUTANEOUS ENDOSCOPIC GASTROSCOPY

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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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