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510(k) K851110

GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS. by The Huxley Instrument Corp. — Product Code HFB

K851110 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.". The FDA issued a decision of Substantially Equivalent on April 8, 1985. The device falls under product code HFB (Forceps, Biopsy, Gynecological), a Class I device regulated under 21 CFR 884.4530. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1985
Date Received
March 19, 1985
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 The Huxley Instrument Corp.

  • K852721 — BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 (September 6, 1985)
  • K853016 — STILLE ANGULAR RONGEUR, 8-3/4 SS 410 (August 7, 1985)
  • K852993 — BONE RONGEURS (August 7, 1985)
  • K853015 — SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 (July 29, 1985)
  • K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 420 (July 26, 1985)
  • K852734 — O.R. SCISSORS, STRAIGHT, 5-1/2+SHP/SHP SS (July 15, 1985)
  • K852713 — RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420 (July 15, 1985)
  • K852719 — MAYO HEGAR NEEDLE HOLDER, G+SS 410 OR 420 (July 15, 1985)
  • K852720 — THUMB DRESSING FORCEPS, 5+SS 410 OR 420 (July 15, 1985)
  • K852730 — CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420 (July 15, 1985)

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