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510(k) K092840

INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL by Instrumed International, Inc. — Product Code HCZ

K092840 is an FDA 510(k) premarket notification submitted by Instrumed International, Inc. for the device "INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL". The FDA issued a decision of Substantially Equivalent on December 3, 2009. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. Instrumed International, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2009
Date Received
September 15, 2009
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 Instrumed International, Inc.

  • K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (August 31, 2010)
  • K100517 — INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX (April 29, 2010)
  • K092544 — INSTRUMED VASCULAR CLAMPS (October 26, 2009)
  • K081651 — INSTRUMED RONGEUR (August 8, 2008)
  • K071771 — INSTRUMED RETRACTORS (August 2, 2007)
  • K040855 — INSTRUMED LAPAROSCOPE AND ACCESSORIES (April 16, 2004)

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)
  • 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)
  • K930039 — FORCEPS: MCGRAVEY, MCINDOE, GILLIS (February 24, 1994)

FDA data resources