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FDA 510(k)

OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID

K-Number: K913987 · 1992-04-13

ApplicantCodman & Shurtleff, Inc.
Decision Date1992-04-13
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1992-04-13 under 510(k) number K913987. The device is classified under product code ITY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID?

OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID is a medical device that received FDA 510(k) clearance on 1992-04-13. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K913987.

When did OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID receive FDA 510(k) clearance?

OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID received FDA 510(k) clearance on 1992-04-13, under 510(k) number K913987.

Who is the listed applicant for OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID?

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

What is the FDA product code for OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID?

The FDA product code for OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID is ITY.

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Related Devices (Code: ITY)

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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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