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510(k) K982142

MOUNTABLE ENDOSCOPIC KNIFE by A.M. Surgical, Inc. — Product Code EMF

K982142 is an FDA 510(k) premarket notification submitted by A.M. Surgical, Inc. for the device "MOUNTABLE ENDOSCOPIC KNIFE". The FDA issued a decision of Substantially Equivalent on December 30, 1998. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. A.M. Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1998
Date Received
June 17, 1998
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 A.M. Surgical, Inc.

  • K191771 — SECURE Screw (October 16, 2019)
  • K191345 — Pegasus System (July 17, 2019)
  • K180087 — A.M. Surgical Intramedullary Fixation Device (May 18, 2018)
  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (March 13, 2008)
  • K042458 — A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM (October 7, 2004)

Other clearances for product code EMF

  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (March 13, 2008)
  • 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)
  • K861947 — SURGICAL KNIFE (June 6, 1986)
  • K854891 — KNIFE (May 2, 1986)
  • K851784 — 27-210 PLASTER KNIFE (REINER) (June 20, 1985)

FDA data resources