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FDA 510(k)

SUBCUTANEOUS TUNNELING NEEDLES & HANDLES

K-Number: K854327 · 1985-11-13

ApplicantConcord Laboratories, Inc.
Decision Date1985-11-13
Product CodeGCB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUBCUTANEOUS TUNNELING NEEDLES & HANDLES is the device name listed in this FDA 510(k) record. The listed applicant is Concord Laboratories, Inc.. It received FDA 510(k) clearance on 1985-11-13 under 510(k) number K854327. The device is classified under product code GCB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUBCUTANEOUS TUNNELING NEEDLES & HANDLES?

SUBCUTANEOUS TUNNELING NEEDLES & HANDLES is a medical device that received FDA 510(k) clearance on 1985-11-13. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K854327.

When did SUBCUTANEOUS TUNNELING NEEDLES & HANDLES receive FDA 510(k) clearance?

SUBCUTANEOUS TUNNELING NEEDLES & HANDLES received FDA 510(k) clearance on 1985-11-13, under 510(k) number K854327.

Who is the listed applicant for SUBCUTANEOUS TUNNELING NEEDLES & HANDLES?

The FDA 510(k) record lists Concord Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUBCUTANEOUS TUNNELING NEEDLES & HANDLES?

The FDA product code for SUBCUTANEOUS TUNNELING NEEDLES & HANDLES is GCB.

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Other records listing Concord Laboratories, Inc. 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.

K883840DRI-VENT ARTERIAL BLOOD SAMPLING KITK871825MECONIUM SUCTION CATHETERK864535TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110K862039CONCORD CARE TRAYK854601SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATHK851134REGIONAL ANESTHESIA TRAYS

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Related Devices (Code: GCB)

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.

K974146PARACENTESIS CATHETER DEVICEAllegiance Healthcare Corp.K930568ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.K923028TURKEL PNEUMOTHORAX KITSymbiosis Corp.K900374ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.K852428MANAN EPIDURAL NEEDLEManan Manufacturing Co., Inc.K780896NEEDLES, DESIGN CHANGE, IV CATHETERSJelco Laboratories

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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