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510(k) K895885

AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING by National-Standard Co. — Product Code FCI

K895885 is an FDA 510(k) premarket notification submitted by National-Standard Co. for the device "AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING". The FDA issued a decision of Substantially Equivalent on February 9, 1990. The device falls under product code FCI (Punch, Biopsy), a Class II device regulated under 21 CFR 876.1075.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1990
Date Received
October 5, 1989
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 for product code FCI

  • 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)
  • K831317 — BIOPSY ATTACHMENT (May 18, 1983)

FDA data resources