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510(k) K863213

KEISEI SCALPEL (STERILE AND NON-STERILE) by Keisei Medical Industrial Co., Ltd. — Product Code GDX

K863213 is an FDA 510(k) premarket notification submitted by Keisei Medical Industrial Co., Ltd. for the device "KEISEI SCALPEL (STERILE AND NON-STERILE)". The FDA issued a decision of Substantially Equivalent on September 2, 1986. The device falls under product code GDX (Scalpel, One-Piece), 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
Scalpel, One-Piece
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)
  • K863211 — KEISEI SURGICAL BLADES (STERILE & NON-STERILE) (September 2, 1986)
  • K863214 — KEISEI MICRO-BLADES (STERILE AND NON-STERILE) (September 2, 1986)

Other clearances for product code GDX

  • K923689 — SURGISTAR BLADES (September 9, 1992)
  • K921167 — ULTRABLADE (July 30, 1992)
  • K914086 — ICAN CYLINDRICAL SPONGES (October 9, 1991)
  • K904505 — CCI CORNEAL SCARIFIER (April 23, 1991)
  • K905380 — 1-CUT ACL GRAFT KNIFE (December 13, 1990)
  • K895682 — VESSEL LOOPS (October 24, 1989)
  • K893033 — MINI-DIAMOND KNIFE (May 26, 1989)
  • K880028 — OMED DISPOSABLE SCALPEL (January 29, 1988)
  • K871894 — KCK INDUSTRIES' SURGICAL INSTRUMENTS (June 23, 1987)
  • K863950 — P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (October 24, 1986)

FDA data resources