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510(k) K861947

SURGICAL KNIFE by Sharpoint, Inc. — Product Code EMF

K861947 is an FDA 510(k) premarket notification submitted by Sharpoint, Inc. for the device "SURGICAL KNIFE". The FDA issued a decision of Substantially Equivalent on June 6, 1986. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. Sharpoint, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1986
Date Received
May 20, 1986
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 by Sharpoint, Inc.

  • K863595 — COATED SUTURE NEEDLE (October 24, 1986)
  • K840764 — EAR KNIVES (May 21, 1984)
  • K840855 — CORNEAL SCLERAL LANCE (May 9, 1984)
  • K840659 — ANTERIOR CAPSULECTOMY CYSTITOME (March 16, 1984)
  • K840660 — POSTERIOR CAPSULOTOMY CYSTITOME (March 16, 1984)
  • K830522 — STAINLESS STEEL SUTURE 316L (March 31, 1983)
  • K822112 — OPHTHALMIC KNIFE (August 10, 1982)
  • K821440 — V LANCE (June 14, 1982)

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)
  • K890217 — MICROSURGICAL KNIVES (January 27, 1989)
  • K890215 — MICROSURGICAL SCARIFIER (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)
  • K854891 — KNIFE (May 2, 1986)
  • K851784 — 27-210 PLASTER KNIFE (REINER) (June 20, 1985)

FDA data resources