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510(k) K891681

DILECTRON URINARY CONDUCTIVITY PROBE by Gyrus Medical , Ltd. — Product Code JRE

K891681 is an FDA 510(k) premarket notification submitted by Gyrus Medical , Ltd. for the device "DILECTRON URINARY CONDUCTIVITY PROBE". The FDA issued a decision of Substantially Equivalent on May 1, 1990. The device falls under product code JRE (Refractometer For Clinical Use), a Class I device regulated under 21 CFR 862.2800. Gyrus Medical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1990
Date Received
March 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer For Clinical Use
Device Class
Class I
Regulation Number
862.2800
Review Panel
CH
Submission Type

Other clearances by Gyrus Medical , Ltd.

  • K050550 — GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR (November 9, 2005)
  • K050460 — GYRUS PLASMACISION AND PLASMABLEND ELECTRODES (October 25, 2005)
  • K041999 — GYRUS PLASMA SKIN RESURFACING SYSTEM (March 2, 2005)
  • K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULA (October 22, 2004)
  • K041285 — GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION (September 10, 2004)
  • K024286 — GYRUS OPEN FORCEPS (November 17, 2003)
  • K031085 — GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) (July 21, 2003)
  • K031081 — EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS (May 21, 2003)
  • K031079 — EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE (May 21, 2003)
  • K031082 — EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK (May 21, 2003)

Other clearances for product code JRE

  • K954977 — URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) (March 11, 1996)
  • K941906 — MODEL 2730 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941901 — MODEL 2721 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941903 — MODEL 2740 CLINICAL REFRACTOMETER (January 17, 1995)
  • K941905 — MODEL 3461 CLINICAL REFRACTOMETER (December 13, 1994)
  • K941902 — MODEL 3471 CLINICAL REFRACTOMETER (December 13, 1994)
  • K941904 — MODEL A300CL CLINICAL REFRACTOMETER (December 13, 1994)
  • K842168 — ATAGO URINE SPECIFIC GRAVITY & SERUM (July 16, 1984)
  • K831213 — SPECIFIC GRAVITY INSTRUMENT (June 30, 1983)
  • K811342 — REAGENT STRIPS FOR URINALYSIS (September 1, 1981)

FDA data resources