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510(k) K893033

MINI-DIAMOND KNIFE by L.A.B. Instruments — Product Code GDX

K893033 is an FDA 510(k) premarket notification submitted by L.A.B. Instruments for the device "MINI-DIAMOND KNIFE". The FDA issued a decision of Substantially Equivalent on May 26, 1989. 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
May 26, 1989
Date Received
April 24, 1989
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)
  • 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)
  • K863213 — KEISEI SCALPEL (STERILE AND NON-STERILE) (September 2, 1986)

FDA data resources