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510(k) K831317

BIOPSY ATTACHMENT by Diasonics, Inc. — Product Code FCI

K831317 is an FDA 510(k) premarket notification submitted by Diasonics, Inc. for the device "BIOPSY ATTACHMENT". The FDA issued a decision of Substantially Equivalent on May 18, 1983. The device falls under product code FCI (Punch, Biopsy), a Class II device regulated under 21 CFR 876.1075. Diasonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1983
Date Received
April 22, 1983
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 Diasonics, Inc.

  • K962662 — VINGMED SOUND COLOR FLOW MAPPING SYSTEM (January 2, 1997)
  • K924079 — CFM-800 COLOR FLOW MAPPING SYSTEM (September 28, 1993)
  • K911435 — CPA/3.5 MHZ PROBE (September 11, 1992)
  • K905200 — SACA, 3.5 MHZ PROBE (April 2, 1992)
  • K903562 — CW DOPPLER 2.25 MHZ PROBE (March 2, 1992)
  • K903984 — CW DOPPLER/4.5 MHZ (June 14, 1991)
  • K896637 — ACCESS(TM), SOFTWARE RELEASE 4.11P (January 22, 1990)
  • K893518 — MT/S SOFTWARE RELEASE 5.0. (October 27, 1989)
  • K894290 — ACCESS TM (September 7, 1989)
  • K893881 — ACCESS TM (June 23, 1989)

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)
  • K875119 — BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE (March 2, 1988)
  • K853104 — DISPOSABLE, STERILE BIOPSY PUNCH (October 4, 1985)

FDA data resources