Home / 510(k) Clearances / K955463

510(k) K955463

GRIP-A-BOOTS by Sil-Med Corp. — Product Code LXZ

K955463 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "GRIP-A-BOOTS". The FDA issued a decision of Substantially Equivalent on January 23, 1996. The device falls under product code LXZ (Guard, Instrument), 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
January 23, 1996
Date Received
November 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guard, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Sil-Med Corp.

  • K972521 — NAVIGATOR (STYLET) 2006 (October 1, 1997)
  • 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)
  • 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 LXZ

  • K834127 — INSTRUMENT TIP PROTECTION COVERS (February 17, 1984)

FDA data resources