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FDA 510(k)

TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE

K-Number: K864219 · 1987-03-27

ApplicantAmedic USA
Decision Date1987-03-27
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Amedic USA. It received FDA 510(k) clearance on 1987-03-27 under 510(k) number K864219. The device is classified under product code HGL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE?

TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE is a medical device that received FDA 510(k) clearance on 1987-03-27. The listed applicant is Amedic USA. The 510(k) number is K864219.

When did TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE receive FDA 510(k) clearance?

TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE received FDA 510(k) clearance on 1987-03-27, under 510(k) number K864219.

Who is the listed applicant for TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE?

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

What is the FDA product code for TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE?

The FDA product code for TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE is HGL.

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Other records listing Amedic USA 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.

K897120EQUIP COVERS, STERILEK892070GENERAL IVT NEEDLE GUIDE KIT, STERILEK892071GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILEK892069EXTENDED COVERS, STERILEK892068TRT (ACUSON) NEEDLE GUIDE KIT, STERILEK871467BIOPSY NEEDLE GUIDE KIT, STERILE

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Related Devices (Code: HGL)

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.

K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.K924516OP3/VP4Huntleigh Technology, Inc.K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEMAdvanced Technology Laboratories, Inc.K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBEHitachi Medical Corp. of AmericaK901142MER MULTIPLANE VAGINAL PROBE (MVP)Medical Equipment Resources

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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