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FDA 510(k)

NEEDLES, DESIGN CHANGE, IV CATHETERS

K-Number: K780896 · 1978-08-23

ApplicantJelco Laboratories
Decision Date1978-08-23
Product CodeGCB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEEDLES, DESIGN CHANGE, IV CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Jelco Laboratories. It received FDA 510(k) clearance on 1978-08-23 under 510(k) number K780896. 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 NEEDLES, DESIGN CHANGE, IV CATHETERS?

NEEDLES, DESIGN CHANGE, IV CATHETERS is a medical device that received FDA 510(k) clearance on 1978-08-23. The listed applicant is Jelco Laboratories. The 510(k) number is K780896.

When did NEEDLES, DESIGN CHANGE, IV CATHETERS receive FDA 510(k) clearance?

NEEDLES, DESIGN CHANGE, IV CATHETERS received FDA 510(k) clearance on 1978-08-23, under 510(k) number K780896.

Who is the listed applicant for NEEDLES, DESIGN CHANGE, IV CATHETERS?

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

What is the FDA product code for NEEDLES, DESIGN CHANGE, IV CATHETERS?

The FDA product code for NEEDLES, DESIGN CHANGE, IV CATHETERS is GCB.

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Other records listing Jelco Laboratories 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.

K791918JELCO WINGED INTRAVASCULAR CATHETERK791372JELCO & KVO CATHETER PLACEMENT UNITK790967CATHETER METAL HUB/RADIOPAQUEK790968CATHETER METAL HUB/NONRADIOPAQUEK790471JELCO* DISC FILTER-0.2 MICRONK790186PROTECTIVSTABILIZER

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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.K854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLESConcord Laboratories, Inc.K852428MANAN EPIDURAL NEEDLEManan Manufacturing Co., 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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