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510(k) K791289

GIZMO TOWEL CLAMP by Hemoy, Inc. — Product Code HXD

K791289 is an FDA 510(k) premarket notification submitted by Hemoy, Inc. for the device "GIZMO TOWEL CLAMP". The FDA issued a decision of Substantially Equivalent on July 24, 1979. The device falls under product code HXD (Clamp), a Class I device regulated under 21 CFR 878.4800. Hemoy, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1979
Date Received
July 10, 1979
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 Hemoy, Inc.

  • K791288 — YELLOW ALERT SYSTEM (August 3, 1979)

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)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)

FDA data resources