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FDA 510(k)

BYRON WORD BARTHOLIAN GLAND CATHETER

K-Number: K861877 · 1986-05-30

ApplicantByron Medical
Decision Date1986-05-30
Product CodeGBA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BYRON WORD BARTHOLIAN GLAND CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1986-05-30 under 510(k) number K861877. The device is classified under product code GBA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BYRON WORD BARTHOLIAN GLAND CATHETER?

BYRON WORD BARTHOLIAN GLAND CATHETER is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Byron Medical. The 510(k) number is K861877.

When did BYRON WORD BARTHOLIAN GLAND CATHETER receive FDA 510(k) clearance?

BYRON WORD BARTHOLIAN GLAND CATHETER received FDA 510(k) clearance on 1986-05-30, under 510(k) number K861877.

Who is the listed applicant for BYRON WORD BARTHOLIAN GLAND CATHETER?

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

What is the FDA product code for BYRON WORD BARTHOLIAN GLAND CATHETER?

The FDA product code for BYRON WORD BARTHOLIAN GLAND CATHETER is GBA.

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Other records listing Byron Medical 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.

K040149PSI-TEC PERISTALTIC INFILTRATION PUMPK001803ACCELERATOR RECIPROCATING CANNULAK981215PSI-TEC LIPOSUCTION ASPIRATORK981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESK980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONK980392PSI-TEC ASPIRATOR

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Related Devices (Code: GBA)

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.

K802025BALLOON RETENTION CHEST CATHETERLoseff Medical Designers, Ltd.K790444ELECATH MULTI-PURPOSE ARTERIAL SURGERElectro-Catheter Corp.K781772CATHETER, TRANSLUMINAL BALLOONMedi-Tech, Inc.K781665TUBE, LEATHERMAN/IMBRUCENational Catheter Co. Div. Mallinckrodt

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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