FDA 510(k)

HOT BIOPSY FORCEPS W/ROUND CUPS

K-Number: K820983 · 1982-04-26

Decision Date1982-04-26

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HOT BIOPSY FORCEPS W/ROUND CUPS 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 1982-04-26 under 510(k) number K820983. 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 HOT BIOPSY FORCEPS W/ROUND CUPS?

HOT BIOPSY FORCEPS W/ROUND CUPS is a medical device that received FDA 510(k) clearance on 1982-04-26. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K820983.

When did HOT BIOPSY FORCEPS W/ROUND CUPS receive FDA 510(k) clearance?

HOT BIOPSY FORCEPS W/ROUND CUPS received FDA 510(k) clearance on 1982-04-26, under 510(k) number K820983.

Who is the listed applicant for HOT BIOPSY FORCEPS W/ROUND CUPS?

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 HOT BIOPSY FORCEPS W/ROUND CUPS?

The FDA product code for HOT BIOPSY FORCEPS W/ROUND CUPS is GEI.

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Other records listing Mill-Rose Laboratory as applicant

K983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT K983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY 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.