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FDA 510(k)

TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL

K-Number: K945320 · 1995-05-11

ApplicantTetra Corp.
Decision Date1995-05-11
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Tetra Corp.. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K945320. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL?

TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Tetra Corp.. The 510(k) number is K945320.

When did TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL receive FDA 510(k) clearance?

TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL received FDA 510(k) clearance on 1995-05-11, under 510(k) number K945320.

Who is the listed applicant for TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL?

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

What is the FDA product code for TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL?

The FDA product code for TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL is ITX.

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Other records listing Tetra 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.

K946277TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEMK945318TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CAK945319TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENTK924204NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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