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FDA 510(k)

FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE

K-Number: K093209 · 2010-02-26

ApplicantCook, Inc.
Decision Date2010-02-26
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2010-02-26 under 510(k) number K093209. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE?

FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE is a medical device that received FDA 510(k) clearance on 2010-02-26. The listed applicant is Cook, Inc.. The 510(k) number is K093209.

When did FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE receive FDA 510(k) clearance?

FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE received FDA 510(k) clearance on 2010-02-26, under 510(k) number K093209.

Who is the listed applicant for FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE?

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

What is the FDA product code for FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE?

The FDA product code for FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE is BSP.

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Other records listing Cook, 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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Related Devices (Code: BSP)

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.

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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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