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510(k) K863808

THE S. CORDERO STYLUS by S. Cordero Co. — Product Code GDZ

K863808 is an FDA 510(k) premarket notification submitted by S. Cordero Co. for the device "THE S. CORDERO STYLUS". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code GDZ (Handle, Scalpel), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1986
Date Received
September 30, 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 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)
  • K863212 — KEISEI HANDLES FOR SURGICAL BLADES (September 2, 1986)
  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K852735 — SCALPEL HANDLE #7 SS 410 OR 420 (July 15, 1985)
  • K852711 — SCALPEL HANDLE #3 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