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510(k) K791286

WECK MICROSURGICAL KNIFE by Vista Medical Products, Inc. — Product Code EMF

K791286 is an FDA 510(k) premarket notification submitted by Vista Medical Products, Inc. for the device "WECK MICROSURGICAL KNIFE". The FDA issued a decision of Substantially Equivalent on July 24, 1979. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1979
Date Received
July 9, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code EMF

  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (March 13, 2008)
  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)
  • K890214 — MICROSURGERY RAZOR BLADE HOLDER (January 27, 1989)
  • K890215 — MICROSURGICAL SCARIFIER (January 27, 1989)
  • K890217 — MICROSURGICAL KNIVES (January 27, 1989)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K863752 — VALTRAC (BAR) REMOVER DEVICE (October 24, 1986)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K861947 — SURGICAL KNIFE (June 6, 1986)
  • K854891 — KNIFE (May 2, 1986)

FDA data resources