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510(k) K100517

INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX by Instrumed International, Inc. — Product Code HDA

K100517 is an FDA 510(k) premarket notification submitted by Instrumed International, Inc. for the device "INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX". The FDA issued a decision of Substantially Equivalent on April 29, 2010. The device falls under product code HDA (Forceps, Obstetrical), a Class II device regulated under 21 CFR 884.4400. Instrumed International, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2010
Date Received
February 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Obstetrical
Device Class
Class II
Regulation Number
884.4400
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)
  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • 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 HDA

  • K092827 — DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX (January 8, 2010)
  • K013747 — TEKNO-MEDICAL OBSTETRICAL FORCEPS (February 11, 2002)
  • K951529 — V. MUELLER OBSTETRICAL (OB) FORCEPS (August 4, 1995)
  • K914552 — CMI VACUUM PUMP (September 7, 1993)
  • K905583 — ILC FORCEPS PADS (April 12, 1991)
  • K903205 — AUTO SUTURE(R) ENDOSCOPIC CLAMP (October 11, 1990)
  • K890385 — MIDWIFERY/OBSTETRICAL FORCEPS (March 1, 1989)
  • K851883 — SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 (May 9, 1985)
  • K771106 — FORCEPS, OB, NON-COMPRESSIVE (July 1, 1977)

FDA data resources