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510(k) K863212

KEISEI HANDLES FOR SURGICAL BLADES by Keisei Medical Industrial Co., Ltd. — Product Code GDZ

K863212 is an FDA 510(k) premarket notification submitted by Keisei Medical Industrial Co., Ltd. for the device "KEISEI HANDLES FOR SURGICAL BLADES". The FDA issued a decision of Substantially Equivalent on September 2, 1986. The device falls under product code GDZ (Handle, 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
Handle, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Keisei Medical Industrial Co., Ltd.

  • K863213 — KEISEI SCALPEL (STERILE AND NON-STERILE) (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 GDZ

  • K091462 — SPECTRA MEDICAL SAFETY SCAPEL (December 15, 2009)
  • K890242 — SCALPEL HANDLE (January 27, 1989)
  • K884512 — BEAVER(R) HANDLE (November 17, 1988)
  • K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE (October 24, 1986)
  • K863808 — THE S. CORDERO STYLUS (October 14, 1986)
  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K852711 — SCALPEL HANDLE #3 SS 410 OR 420 (July 15, 1985)
  • K852735 — SCALPEL HANDLE #7 SS 410 OR 420 (July 15, 1985)
  • K851750 — 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 (June 20, 1985)
  • K852042 — BRIMFIELD CANNULATED BLADE HOLDER (June 11, 1985)

FDA data resources