FDA 510(k)

DYNABITE UROLOGICAL FORCEPS

K-Number: K952391 · 1995-06-01

Decision Date1995-06-01

Product CodeFCL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DYNABITE UROLOGICAL FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Portlyn Corp.. It received FDA 510(k) clearance on 1995-06-01 under 510(k) number K952391. The device is classified under product code FCL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNABITE UROLOGICAL FORCEPS?

DYNABITE UROLOGICAL FORCEPS is a medical device that received FDA 510(k) clearance on 1995-06-01. The listed applicant is Portlyn Corp.. The 510(k) number is K952391.

When did DYNABITE UROLOGICAL FORCEPS receive FDA 510(k) clearance?

DYNABITE UROLOGICAL FORCEPS received FDA 510(k) clearance on 1995-06-01, under 510(k) number K952391.

Who is the listed applicant for DYNABITE UROLOGICAL FORCEPS?

The FDA 510(k) record lists Portlyn Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNABITE UROLOGICAL FORCEPS?

The FDA product code for DYNABITE UROLOGICAL FORCEPS is FCL.

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Other records listing Portlyn Corp. as applicant

K970083DYNABITE HOT GI BIOPSY FORCEPS K951447DYNABITE CARDIOVASCULAR BIOPSY FORCEPS K944245DYNABITE LAPAROSCOPIC FORCEPS K934506DYNABITE HYSTEROSCOPIC FORCEPS K901300BIOPSY FORCEPS K896147BIOPSY FORCEP (NON-ELECTRIC)

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Related Devices (Code: FCL)

K032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEOlympus Optical Co., Ltd.K973611SPECTRASCIENCE REUSABLE BIOPSY FORCEPSSpectrascience, Inc.K971315AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.K964120INJECTO FLUSHRobert J. Jynch, Jr.K963517SPECTRA SCIENCE BIOPSY FORCEPSSpectrascience, Inc.K955065OLYMPUS FB SERIES BIOPSY FORCEPSOlympus America, Inc.

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.