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510(k) K941356

MICROFLOW IRRIGATION SYSTEM by Jedmed Instrument Co. — Product Code GBQ

K941356 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "MICROFLOW IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 19, 1994. The device falls under product code GBQ (Catheter, Continuous Irrigation), a Class I device regulated under 21 CFR 878.4200. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1994
Date Received
March 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Jedmed Instrument Co.

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (September 15, 1995)
  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 1995)
  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K950078 — MICROFLOW IRRIGATION SYSTEM (June 21, 1995)
  • K944671 — VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (February 7, 1995)

Other clearances for product code GBQ

  • K921464 — CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT (May 5, 1992)
  • K882647 — GESCO CATHETERIZATION TRAY (September 9, 1988)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K872787 — MODIFIED CURLCATH (August 4, 1987)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K771732 — THORNTON ANTERIOR CHAMBER IRRIGATOR (September 28, 1977)

FDA data resources