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510(k) K855104

ANGIOMED SKIN FASCIA KNIFE by Angiomed U.S., Inc. — Product Code GES

K855104 is an FDA 510(k) premarket notification submitted by Angiomed U.S., Inc. for the device "ANGIOMED SKIN FASCIA KNIFE". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Angiomed U.S., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
December 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Angiomed U.S., Inc.

  • K874771 — ANGIOMED INTRODUCING SETS (January 12, 1988)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT (January 30, 1987)
  • K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS (October 24, 1986)
  • K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE (September 29, 1986)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K854910 — ANGIOFLOW (July 17, 1986)
  • K854912 — ANGIOMED GUIED WIRES (April 16, 1986)
  • K854908 — UROFLEX (March 14, 1986)
  • K855076 — ANGIOMED URETER DIATION SETS (March 11, 1986)

Other clearances for product code GES

  • K032242 — PERSONNA PLUS SAFETY SCALPEL SYSTEM (September 23, 2003)
  • K932998 — EASY-ON (August 18, 1993)
  • K923170 — LOS ALAMOS RETRACTABLE KNIFE (February 18, 1993)
  • K915119 — SCALPEL BLADE REMOVER (BLADEGARD) (May 5, 1992)
  • K911913 — PRECISION GLIDE - ENHANCED SURGICAL BLADE (May 13, 1991)
  • K900266 — STERILE CARBON STEEL SURGICAL BLADE (March 1, 1990)
  • K884862 — ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (December 27, 1988)
  • K881638 — SURGICAL BLADE (June 15, 1988)
  • K880244 — SURGICAL BLADES (February 10, 1988)
  • K873493 — NINJA SCALPEL (September 24, 1987)

FDA data resources