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510(k) K760877

MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT by Sherwood Medical Industries — Product Code CCT

K760877 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1976
Date Received
October 4, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator (Laryngo-Tracheal), Topical Anesthesia
Device Class
Class II
Regulation Number
868.5170
Review Panel
AN
Submission Type

Other clearances by Sherwood Medical Industries

  • K801070 — SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (July 21, 1980)
  • K801071 — LANCER GLUCOSE RATE REAGENT KIT (May 23, 1980)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K782077 — LANCER ICE CUBE (April 3, 1979)
  • K790523 — ARGYLE ESOPHAGEAL STETHOSCOPE (March 27, 1979)
  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)

Other clearances for product code CCT

  • K240114 — UltraEzAir® (UEA1A) (October 16, 2024)
  • K172956 — Medicant Mucosal Atomizer (April 6, 2018)
  • K153470 — MADgic Laryngo-Tracheal Mucosal Atomization Device (August 19, 2016)
  • K093584 — EZ-MISTER (March 4, 2011)
  • K070596 — TOPICAL APPLICATOR (June 21, 2007)
  • K002255 — LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (September 18, 2000)
  • K894755 — ASTRA DISPOSABLE SPRAY CANNULA (January 12, 1990)
  • K810059 — ENDO-MED TUBE FOR ENDOTRACHEAL MED (February 26, 1981)
  • K760759 — ANESTHESIA KIT (December 9, 1976)

FDA data resources