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510(k) K080133

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

K080133 is an FDA 510(k) premarket notification submitted by A.M. Surgical, Inc. for the device "MOUNTABLE ENDOSCOPIC BLADE". The FDA issued a decision of Substantially Equivalent on March 13, 2008. 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
March 13, 2008
Date Received
January 18, 2008
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)
  • K042458 — A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM (October 7, 2004)
  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)

Other clearances for product code EMF

  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)
  • K890215 — MICROSURGICAL SCARIFIER (January 27, 1989)
  • K890214 — MICROSURGERY RAZOR BLADE HOLDER (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)
  • K851784 — 27-210 PLASTER KNIFE (REINER) (June 20, 1985)

FDA data resources