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510(k) K840352

CIN-SHEAR by Roland J. Zwick, Inc. — Product Code HFB

K840352 is an FDA 510(k) premarket notification submitted by Roland J. Zwick, Inc. for the device "CIN-SHEAR". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Roland J. Zwick, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
January 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Gynecological
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Roland J. Zwick, Inc.

  • K860796 — DISPO-URETTE (April 8, 1986)

Other clearances for product code HFB

  • K011488 — SPIRABRUSH CX BIOPSY INSTRUMENT (February 22, 2002)
  • K944444 — CIT BIOPSY PUNCHES (September 29, 1995)
  • K930773 — SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS (July 28, 1994)
  • K933767 — FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY (May 26, 1994)
  • K926595 — OWENS BIOPSY FORCEPS (May 25, 1994)
  • K926527 — ROTO FIT BIOPSY FORCEPS (February 25, 1994)
  • K930036 — THOMAS MEDICAL BIOPSY FORCEPS (February 24, 1994)
  • K926538 — TISCHLER BIOPSY FORCEPS (February 24, 1994)
  • K924224 — OWENS BIOPSY FORCEPS (February 4, 1994)
  • K902049 — CROAK OVARIAN BIOPSY FORCEP (June 7, 1990)

FDA data resources