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FDA 510(k)

ENTREE NEEDLE

K-Number: K914426 · 1991-11-27

ApplicantCore Dynamics, Inc.
Decision Date1991-11-27
Product CodeFHO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTREE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Core Dynamics, Inc.. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K914426. The device is classified under product code FHO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTREE NEEDLE?

ENTREE NEEDLE is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Core Dynamics, Inc.. The 510(k) number is K914426.

When did ENTREE NEEDLE receive FDA 510(k) clearance?

ENTREE NEEDLE received FDA 510(k) clearance on 1991-11-27, under 510(k) number K914426.

Who is the listed applicant for ENTREE NEEDLE?

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

What is the FDA product code for ENTREE NEEDLE?

The FDA product code for ENTREE NEEDLE is FHO.

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Other records listing Core Dynamics, 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.

K992250CORE AUDIBLE TROCAR IIK992190CORE POUCHK955490LAPAROSCOPIC KNITTERK953903LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MMK953409LAPAROSCOPIC TROCARK950457CANNUAL AND TROCAR, SUPERPUBIC

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Related Devices (Code: FHO)

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.

K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,LtdK121370VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLEVectecK010779MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTGibbons Surgical Corp.K970788PNEUMO-MATIC INSUFFLATION NEEDLEApple Medical Corp.K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMSherwood Medical Co.K951894ACCESS EXPANSION SYSTEMMicro-Medical Devices, 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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