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510(k) K830610

FLAT SUCTION DRAIN by Sil-Med Corp. — Product Code GBC

K830610 is an FDA 510(k) premarket notification submitted by Sil-Med Corp. for the device "FLAT SUCTION DRAIN". The FDA issued a decision of Substantially Equivalent on March 29, 1983. The device falls under product code GBC (Lamp, Surgical, Incandescent), a Class II device regulated under 21 CFR 878.4580. Sil-Med Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1983
Date Received
February 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical, Incandescent
Device Class
Class II
Regulation Number
878.4580
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)
  • 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)

Other clearances for product code GBC

  • K896961 — HALUX EXLITE MINOR SURGERY LIGHT (February 22, 1990)
  • K811311 — SKYTRON ELITE SURGICAL TABLES (June 2, 1981)
  • K810207 — MINOR SURGERY LIGHT (February 13, 1981)

FDA data resources