Home / 510(k) Clearances / K760810

510(k) K760810

TUBE, GASTRO-ENTEROSTOMY by Sherwood Medical Industries — Product Code EXD

K760810 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "TUBE, GASTRO-ENTEROSTOMY". The FDA issued a decision of Substantially Equivalent on February 28, 1977. The device falls under product code EXD (Irrigator, Ostomy), a Class II device regulated under 21 CFR 876.5895. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1977
Date Received
October 2, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Ostomy
Device Class
Class II
Regulation Number
876.5895
Review Panel
GU
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 EXD

  • K121833 — OSTOMY IRRIGATION SET (July 16, 2012)
  • K914692 — URINARY DIVERSION EVACUATING CATHETER (July 2, 1992)
  • K904586 — PALEX IRRIGATION SET (December 28, 1990)
  • K871791 — BLOXOM IRRIGATOR (May 20, 1987)
  • K840268 — IRRIGATION SYSTEM (April 5, 1984)
  • K832299 — VISI-FLOW IRRIGATOR (August 26, 1983)
  • K823274 — UNI-TIP COLOSTOMY IRRIGATION CONE (December 7, 1982)
  • K811160 — SUR-FIT IRRIGATION SLEEVE (June 2, 1981)
  • K790749 — COLOSTOMY ENEMA DEVICE (May 16, 1979)
  • K790750 — COLOSTOMY DEVICE W/ PRESSURE LID (May 14, 1979)

FDA data resources