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510(k) K944444

CIT BIOPSY PUNCHES by Chirurgische Instrumente — Product Code HFB

K944444 is an FDA 510(k) premarket notification submitted by Chirurgische Instrumente for the device "CIT BIOPSY PUNCHES". The FDA issued a decision of Substantially Equivalent on September 29, 1995. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Chirurgische Instrumente has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
August 12, 1994
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 Chirurgische Instrumente

  • K944270 — CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS (July 25, 1995)
  • K944268 — CIT TWO WAY SUCTIN AND IRRIGATION TUBES (January 26, 1995)
  • K944269 — CIT GRASPING AND DISSECTING FORCEPS (January 24, 1995)

Other clearances for product code HFB

  • K011488 — SPIRABRUSH CX BIOPSY INSTRUMENT (February 22, 2002)
  • 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)
  • K895303 — EVER-SHARP BIOPSY FORCEPS (January 16, 1990)

FDA data resources