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510(k) K853104

DISPOSABLE, STERILE BIOPSY PUNCH by August C. Stiefel Research Institute, Inc. — Product Code FCI

K853104 is an FDA 510(k) premarket notification submitted by August C. Stiefel Research Institute, Inc. for the device "DISPOSABLE, STERILE BIOPSY PUNCH". The FDA issued a decision of Substantially Equivalent on October 4, 1985. 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
October 4, 1985
Date Received
July 23, 1985
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

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

FDA data resources