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510(k) K902049

CROAK OVARIAN BIOPSY FORCEP by Gynescope Corp. — Product Code HFB

K902049 is an FDA 510(k) premarket notification submitted by Gynescope Corp. for the device "CROAK OVARIAN BIOPSY FORCEP". The FDA issued a decision of Substantially Equivalent on June 7, 1990. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. Gynescope Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1990
Date Received
May 7, 1990
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 Gynescope Corp.

  • K902657 — GYNESCOPE LAPAROSCOPIC FORCEPS (September 19, 1990)
  • K902658 — GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES (September 19, 1990)
  • K901530 — WALLACE INTRAUTERINE INSEMINATION CATHETER (July 23, 1990)
  • K902655 — GYNESCOPE LAPAROSCOPES (July 13, 1990)
  • K902656 — GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES (June 29, 1990)
  • K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (June 7, 1990)
  • K900878 — OTT INSUFFLATION FILTER TUBING (May 7, 1990)
  • K895225 — GYNECOLOGICAL INSTRUMENTATION (March 5, 1990)

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)
  • K895303 — EVER-SHARP BIOPSY FORCEPS (January 16, 1990)

FDA data resources