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FDA 510(k)

SITERITE NEEDLE GUIDE

K-Number: K903158 · 1990-09-27

ApplicantDymax Corp
Decision Date1990-09-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SITERITE NEEDLE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Dymax Corp. It received FDA 510(k) clearance on 1990-09-27 under 510(k) number K903158. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SITERITE NEEDLE GUIDE?

SITERITE NEEDLE GUIDE is a medical device that received FDA 510(k) clearance on 1990-09-27. The listed applicant is Dymax Corp. The 510(k) number is K903158.

When did SITERITE NEEDLE GUIDE receive FDA 510(k) clearance?

SITERITE NEEDLE GUIDE received FDA 510(k) clearance on 1990-09-27, under 510(k) number K903158.

Who is the listed applicant for SITERITE NEEDLE GUIDE?

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

What is the FDA product code for SITERITE NEEDLE GUIDE?

The FDA product code for SITERITE NEEDLE GUIDE is DQY.

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Other records listing Dymax Corp 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.

K032135SITE-RITE IV ULTRASOUND SYSTEMK993624SITE-RITE 3 ULTRASOUND SYSTEMK931403SITERITE NEEDLE GUIDE (MODIFIED)K894415DYMAX ENDOVAGINAL BIOPSY GUIDEK862127DYMAX PERSONAL SCANNERK850478PLUS 1

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Related Devices (Code: DQY)

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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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