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510(k) K812070

BORES* ADJUSTABLE BLADE HOLDER by Santa Barbara Medco, Inc. — Product Code GDZ

K812070 is an FDA 510(k) premarket notification submitted by Santa Barbara Medco, Inc. for the device "BORES* ADJUSTABLE BLADE HOLDER". The FDA issued a decision of Substantially Equivalent on August 18, 1981. The device falls under product code GDZ (Handle, Scalpel), a Class I device regulated under 21 CFR 878.4800. Santa Barbara Medco, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1981
Date Received
July 21, 1981
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 Santa Barbara Medco, Inc.

  • K850492 — NASAL SEPTAL BUTTON (March 7, 1985)
  • K842483 — SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC (August 31, 1984)
  • K823921 — PHYSICIANS CHOICE SILICONE EAR PUTTY (March 28, 1983)
  • K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT (May 27, 1982)
  • K812069 — BORES* DEPTH GAUGE (August 31, 1981)
  • K812071 — RK IV SURGICAL BLADES (August 31, 1981)
  • K802638 — OTOLOGICAL VENTILATION TUBES (November 12, 1980)

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)
  • 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)

FDA data resources