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510(k) K972521

NAVIGATOR (STYLET) 2006 by Sil-Med Corp. — Product Code GAH

K972521 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "NAVIGATOR (STYLET) 2006". The FDA issued a decision of Substantially Equivalent on October 1, 1997. The device falls under product code GAH (Stylet, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Sil-Med Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1997
Date Received
July 7, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Sil-Med Corp.

  • K961392 — ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II (July 18, 1997)
  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (June 26, 1996)
  • K960099 — PENROSE DRAIN MODELS 6001 - 6007 (March 11, 1996)
  • K955463 — GRIP-A-BOOTS (January 23, 1996)
  • K942709 — MEDIASTINAL SILICONE DRAINS (January 4, 1996)
  • K926496 — SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN (May 24, 1995)
  • K926495 — SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE (February 2, 1994)
  • K926408 — SIL-SLIP FLAT SUCTION DRAIN (February 2, 1994)
  • K921424 — SIL-MED FLAT SUCTION DRAIN (September 28, 1992)

Other clearances for product code GAH

  • K110355 — VENX REVOLUTION (April 22, 2011)
  • K000932 — ARACHNOPHLEBECTOMY NEEDLE (May 17, 2000)
  • K970306 — MARKMAN TEMPLATE SYSTEM (November 20, 1997)
  • K972918 — RAPID FIRE HAIR IMPLANTER CAROUSEL (October 27, 1997)
  • K952737 — CALVITRON HAIR TRANSPLANT SYSTEM (October 3, 1995)
  • K770970 — HAIR TRANSPLANT PUNCH, MULTIPLH (October 27, 1977)

FDA data resources