Home / 510(k) Clearances / K871894

510(k) K871894

KCK INDUSTRIES' SURGICAL INSTRUMENTS by Kck Industries — Product Code GDX

K871894 is an FDA 510(k) premarket notification submitted by Kck Industries for the device "KCK INDUSTRIES' SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on June 23, 1987. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1987
Date Received
May 1, 1987
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 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)
  • K863950 — P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL (October 24, 1986)
  • K863213 — KEISEI SCALPEL (STERILE AND NON-STERILE) (September 2, 1986)

FDA data resources