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FDA 510(k)

GENERAL IVT NEEDLE GUIDE KIT, STERILE

K-Number: K892070 · 1989-09-05

ApplicantAmedic USA
Decision Date1989-09-05
Product CodeHGL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GENERAL IVT NEEDLE GUIDE KIT, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Amedic USA. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K892070. 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 GENERAL IVT NEEDLE GUIDE KIT, STERILE?

GENERAL IVT NEEDLE GUIDE KIT, STERILE is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Amedic USA. The 510(k) number is K892070.

When did GENERAL IVT NEEDLE GUIDE KIT, STERILE receive FDA 510(k) clearance?

GENERAL IVT NEEDLE GUIDE KIT, STERILE received FDA 510(k) clearance on 1989-09-05, under 510(k) number K892070.

Who is the listed applicant for GENERAL IVT NEEDLE GUIDE KIT, STERILE?

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 GENERAL IVT NEEDLE GUIDE KIT, STERILE?

The FDA product code for GENERAL IVT NEEDLE GUIDE KIT, STERILE 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, STERILEK892071GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILEK892069EXTENDED COVERS, STERILEK892068TRT (ACUSON) NEEDLE GUIDE KIT, STERILEK871467BIOPSY NEEDLE GUIDE KIT, STERILEK871565ULTRASOUND TRANSDUCER GEL, 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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