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510(k) K781664

SILASTIC NEPHROSTOMY SYSTEM by Dow Corning Corp. Healthcare Industries Materials — Product Code GBO

K781664 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "SILASTIC NEPHROSTOMY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 22, 1979. The device falls under product code GBO (Catheter, Nephrostomy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1979
Date Received
September 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Dow Corning Corp. Healthcare Industries Materials

  • K853186 — SILASTIC INFLATABLE BONE PLUG H.P. (September 24, 1985)
  • K844637 — WHITESIDE ACRYLIC CEMENT SPACER SLEEVE (June 19, 1985)
  • K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (May 1, 1985)
  • K843995 — TF-II HIP PROSTHESIS (April 23, 1985)
  • K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (December 20, 1984)
  • K840357 — SSA HIP PROSTHESIS (February 17, 1984)
  • K831479 — METAL-BACKED ACETABULAR CUP (June 15, 1983)
  • K812864 — SILASTIC VOICE PROSTHESIS (November 24, 1981)
  • K812053 — SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) (August 18, 1981)
  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)

Other clearances for product code GBO

  • K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETE (August 19, 2004)
  • K021632 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKIN (June 13, 2002)
  • K912109 — URESIL GENERAL PURPOSE DRAINAGE CATHETER (August 12, 1991)
  • K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) (January 24, 1986)
  • K854911 — PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) (January 24, 1986)
  • K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO) (January 24, 1986)
  • K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) (January 24, 1986)
  • K854909 — PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS (January 24, 1986)
  • K820867 — PERCUTANEOUS NEPHROSTOMY SET (April 13, 1982)
  • K781526 — SILASTIC U-TUBE KIT (September 20, 1978)

FDA data resources