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510(k) K851654

OMNIMED CLAMP by Omni Intl., Inc. — Product Code HXD

K851654 is an FDA 510(k) premarket notification submitted by Omni Intl., Inc. for the device "OMNIMED CLAMP". The FDA issued a decision of Substantially Equivalent on May 31, 1985. The device falls under product code HXD (Clamp), a Class I device regulated under 21 CFR 878.4800. Omni Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1985
Date Received
April 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Omni Intl., Inc.

  • K984066 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM (January 13, 1999)
  • K984064 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE (January 8, 1999)
  • K853255 — OMNIMED I.V. SOLUTION ADMIN. SET (August 23, 1985)
  • K851938 — OMNIMED SURGICAL GOWN (June 28, 1985)
  • K851734 — OMNIMED SUPERIOR TRANSDUCER PROTECTOR (May 23, 1985)
  • K850706 — F-SERIES IMPLANT (April 10, 1985)
  • K850112 — OMNIMED IV SOLUTION ADMINISTRATION SET (February 22, 1985)
  • K850066 — OMNIMED NASAL OXYGEN CANNULA (January 24, 1985)
  • K831147 — OMNIPROBE ELECTRICAL NERVE STIMULATOR (July 18, 1983)
  • K821523 — OMNI TENS (June 16, 1982)

Other clearances for product code HXD

  • K890381 — PARAMETRIUM CLAMP (February 3, 1989)
  • K890368 — KIDNEY CLAMP (February 3, 1989)
  • K890372 — INTESTINAL CLAMP (February 3, 1989)
  • K890371 — INTESTINAL CRUSHING CLAMP (February 3, 1989)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K872386 — C CLAMP (July 2, 1987)
  • K863653 — SUCTION-OFF (October 7, 1986)
  • K853538 — CANNULA CLAMP (September 12, 1985)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)
  • K801028 — RICA OR SMIC SURGICAL INSTRUMENTS (May 20, 1980)

FDA data resources