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510(k) K933767

FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY by Mahe-Medizintechnik — Product Code HFB

K933767 is an FDA 510(k) premarket notification submitted by Mahe-Medizintechnik for the device "FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY". The FDA issued a decision of Substantially Equivalent on May 26, 1994. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Mahe-Medizintechnik has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1994
Date Received
July 29, 1993
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 Mahe-Medizintechnik

  • K942821 — MAHE INSTRUMENTS (November 2, 1994)
  • K942819 — TROCAR WITH SHIELD (August 23, 1994)
  • K933768 — COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES (June 27, 1994)
  • K933770 — FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE (March 23, 1994)
  • K935442 — MAHE INSTRUMENTS (March 14, 1994)
  • K933772 — PUNCH SURGICAL (February 1, 1994)
  • K925624 — MICROSURGICAL INSTRUMENTS (July 22, 1993)

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)
  • 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