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FDA 510(k)

COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720

K-Number: K844993 · 1985-02-28

ApplicantOmnis Surgical, Inc.
Decision Date1985-02-28
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 is the device name listed in this FDA 510(k) record. The listed applicant is Omnis Surgical, Inc.. It received FDA 510(k) clearance on 1985-02-28 under 510(k) number K844993. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720?

COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 is a medical device that received FDA 510(k) clearance on 1985-02-28. The listed applicant is Omnis Surgical, Inc.. The 510(k) number is K844993.

When did COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 receive FDA 510(k) clearance?

COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 received FDA 510(k) clearance on 1985-02-28, under 510(k) number K844993.

Who is the listed applicant for COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720?

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

What is the FDA product code for COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720?

The FDA product code for COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 is FCG.

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Other records listing Omnis Surgical, 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.

K854518EPIDURAL ANESTHESIA TRAYK850979HEMOCONCENTRATOR KITK843595CARDIOTOMY RESERVOIR W/FILTER

Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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