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510(k) K926595

OWENS BIOPSY FORCEPS by Owens Industries, Inc. — Product Code HFB

K926595 is an FDA 510(k) premarket notification submitted by Owens Industries, Inc. for the device "OWENS BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on May 25, 1994. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Owens Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1994
Date Received
September 9, 1992
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 Owens Industries, Inc.

  • K926596 — OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES (June 10, 1994)
  • K926594 — OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES (June 6, 1994)
  • K932796 — OWENS TROCAR (February 2, 1994)

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)
  • 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