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510(k) K091462

SPECTRA MEDICAL SAFETY SCAPEL by Spectra, Inc. — Product Code GDZ

K091462 is an FDA 510(k) premarket notification submitted by Spectra, Inc. for the device "SPECTRA MEDICAL SAFETY SCAPEL". The FDA issued a decision of Substantially Equivalent on December 15, 2009. 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
December 15, 2009
Date Received
May 18, 2009
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

  • 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)
  • K863212 — KEISEI HANDLES FOR SURGICAL BLADES (September 2, 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