FDA 510(k)

DIATHERMIC HANDLE FOR BIOPSY FORCEPS

K-Number: K820971 · 1982-04-29

Decision Date1982-04-29

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DIATHERMIC HANDLE FOR BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Mill-Rose Laboratory. It received FDA 510(k) clearance on 1982-04-29 under 510(k) number K820971. 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 DIATHERMIC HANDLE FOR BIOPSY FORCEPS?

DIATHERMIC HANDLE FOR BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K820971.

When did DIATHERMIC HANDLE FOR BIOPSY FORCEPS receive FDA 510(k) clearance?

DIATHERMIC HANDLE FOR BIOPSY FORCEPS received FDA 510(k) clearance on 1982-04-29, under 510(k) number K820971.

Who is the listed applicant for DIATHERMIC HANDLE FOR BIOPSY FORCEPS?

The FDA 510(k) record lists Mill-Rose Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIATHERMIC HANDLE FOR BIOPSY FORCEPS?

The FDA product code for DIATHERMIC HANDLE FOR BIOPSY FORCEPS is GEI.

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Other records listing Mill-Rose Laboratory as applicant

K983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT K983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT K971275MILL-ROSE DISPOSABLE POLYPECTOMY SNARE K962736MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE K960880MILL-ROSE BLIND MICROBIOLOGY BRUSH K954519WANG TRANSENDOSCOPIC ASPIRATION NEEDLE

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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.