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510(k) K852042

BRIMFIELD CANNULATED BLADE HOLDER by Brimfield Scientific Instruments — Product Code GDZ

K852042 is an FDA 510(k) premarket notification submitted by Brimfield Scientific Instruments for the device "BRIMFIELD CANNULATED BLADE HOLDER". The FDA issued a decision of Substantially Equivalent on June 11, 1985. The device falls under product code GDZ (Handle, Scalpel), a Class I device regulated under 21 CFR 878.4800. Brimfield Scientific Instruments has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1985
Date Received
May 9, 1985
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 Brimfield Scientific Instruments

  • K843135 — BRIMFIELD CANNULATED MAGNETIC RETRIEVER (September 26, 1984)
  • K843136 — BRIMFIELD CANNULATED GRASPING HOOKS (September 25, 1984)
  • K841731 — BRIMFIELD FIBEROPTIC LIGHT SCOURCE (July 16, 1984)
  • K832147 — CIRCUT 1 (July 26, 1983)

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)
  • 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)

FDA data resources