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510(k) K833872

SAV-A-LIMB by Sil-Med Corp. — Product Code KYR

K833872 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "SAV-A-LIMB". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code KYR (Bag, Ice), a Class I device regulated under 21 CFR 880.6050. Sil-Med Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
November 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Ice
Device Class
Class I
Regulation Number
880.6050
Review Panel
HO
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)
  • 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)
  • K926408 — SIL-SLIP FLAT SUCTION DRAIN (February 2, 1994)
  • K926495 — SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE (February 2, 1994)

Other clearances for product code KYR

  • K810653 — VINYL ICE BAG (March 27, 1981)
  • K780608 — ICE BAG, VINYL (June 6, 1978)
  • K760951 — DEVON COOL FACE (December 30, 1976)

FDA data resources