Biopsy Attach. for Adms Ultrasound Probe

FDA 510(k) K875119 · Advanced Diagnostic Medical Systems, Inc.

Substantially Equivalent

510(k) numberK875119

Submission

Device name
Biopsy Attach. for Adms Ultrasound Probe
Applicant
Advanced Diagnostic Medical Systems, Inc.
Dublin, CA, US
Received
December 15, 1987
Decision date
March 2, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FCI – Punch, Biopsy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FCI

510(k)DeviceApplicantDecision
K895885Automated Disposable Soft Tissue Biopsy CuttingFCI · Traditional National-Standard Co.02/09/1990SE
K894627BT-338N Electronic Clinical ThermometerFCI · Traditional Integrated Display Technology, Ltd.10/23/1989SE
K853104Disposable, Sterile Biopsy PunchFCI · Traditional August C. Stiefel Research Institute, Inc.10/04/1985SE
K831317Biopsy AttachmentFCI · Traditional Diasonics, Inc.05/18/1983SE

More from Diasonics, Inc.

510(k)DeviceDecision
K882746Adms Silent Needle GunKNW · Traditional 03/17/1989SE
K890203Adms Biopsy NeedleFCG · Traditional 03/08/1989SE
K881208Probe Sheath for Adms Ultrasound ProbeIYO · Traditional 05/16/1988SE

Questions and answers

When was Biopsy Attach. for Adms Ultrasound Probe cleared by the FDA?

Biopsy Attach. for Adms Ultrasound Probe (K875119) received a 510(k) decision of Substantially Equivalent on March 2, 1988, 78 days after the submission was received.

What is the product code of K875119?

The FDA product code is FCI – Punch, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.