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510(k) K875119

BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE by Advanced Diagnostic Medical Systems, Inc. — Product Code FCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Punch, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Advanced Diagnostic Medical Systems, Inc.

  • K882746 — ADMS SILENT NEEDLE GUN (March 17, 1989)
  • K890203 — ADMS BIOPSY NEEDLE (March 8, 1989)
  • K881208 — PROBE SHEATH FOR ADMS ULTRASOUND PROBE (May 16, 1988)

Other clearances for product code FCI

  • K895885 — AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING (February 9, 1990)
  • K894627 — BT-338N ELECTRONIC CLINICAL THERMOMETER (October 23, 1989)
  • K853104 — DISPOSABLE, STERILE BIOPSY PUNCH (October 4, 1985)
  • K831317 — BIOPSY ATTACHMENT (May 18, 1983)