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510(k) K852721

BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 by The Huxley Instrument Corp. — Product Code HCZ

K852721 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420". The FDA issued a decision of Substantially Equivalent on September 6, 1985. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II 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
September 6, 1985
Date Received
June 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Surgical, Gynecological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by The Huxley Instrument Corp.

  • K852993 — BONE RONGEURS (August 7, 1985)
  • K853016 — STILLE ANGULAR RONGEUR, 8-3/4 SS 410 (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)
  • K852728 — KELLY HEMOSTATIC FORCEPS, STRAIGHT 5-1/2+SS (July 15, 1985)

Other clearances for product code HCZ

  • K172661 — Fetzer Medical Gynecological Forceps (May 8, 2018)
  • K134047 — JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOI (April 11, 2014)
  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K944055 — FORCEPS, SURGICAL GYNECOLOGICAL (September 20, 1994)
  • K941528 — PEARL PACKING FORCEPS (May 12, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926528 — OVUM FORCEPS (February 24, 1994)
  • K930799 — VARIOUS FORCEPS (February 24, 1994)

FDA data resources