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FDA 510(k)

NEWMAN CANNULAE SYSTEM (NCS)

K-Number: K862936 · 1986-08-14

ApplicantByron Medical
Decision Date1986-08-14
Product CodeGEA
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

NEWMAN CANNULAE SYSTEM (NCS) is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1986-08-14 under 510(k) number K862936. The device is classified under product code GEA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NEWMAN CANNULAE SYSTEM (NCS)?

NEWMAN CANNULAE SYSTEM (NCS) is a medical device that received FDA 510(k) clearance on 1986-08-14. The listed applicant is Byron Medical. The 510(k) number is K862936.

When did NEWMAN CANNULAE SYSTEM (NCS) receive FDA 510(k) clearance?

NEWMAN CANNULAE SYSTEM (NCS) received FDA 510(k) clearance on 1986-08-14, under 510(k) number K862936.

Who is the listed applicant for NEWMAN CANNULAE SYSTEM (NCS)?

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 NEWMAN CANNULAE SYSTEM (NCS)?

The FDA product code for NEWMAN CANNULAE SYSTEM (NCS) is GEA.

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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: GEA)

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.

K003965MRI SAFE INSTRUMENTSAesculap, Inc.K982472GENICON TROCARGenicon, LCK954599CONMED TROGARD ELECTRONIC TROCAR SYSTEMConmedcorpK922460ORIGIN SECONDARY CANNULA AND TROCAROrigin Medsystems, Inc.K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEETHICON, Inc.K911262DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCERETHICON, 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.

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