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510(k) K863211

KEISEI SURGICAL BLADES (STERILE & NON-STERILE) by Keisei Medical Industrial Co., Ltd. — Product Code GES

K863211 is an FDA 510(k) premarket notification submitted by Keisei Medical Industrial Co., Ltd. for the device "KEISEI SURGICAL BLADES (STERILE & NON-STERILE)". The FDA issued a decision of Substantially Equivalent on September 2, 1986. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Keisei Medical Industrial Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1986
Date Received
August 20, 1986
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 Keisei Medical Industrial Co., Ltd.

  • K863212 — KEISEI HANDLES FOR SURGICAL BLADES (September 2, 1986)
  • K863213 — KEISEI SCALPEL (STERILE AND NON-STERILE) (September 2, 1986)
  • K863214 — KEISEI MICRO-BLADES (STERILE AND NON-STERILE) (September 2, 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