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510(k) K894415

DYMAX ENDOVAGINAL BIOPSY GUIDE by Dymax Corp — Product Code HGL

K894415 is an FDA 510(k) premarket notification submitted by Dymax Corp for the device "DYMAX ENDOVAGINAL BIOPSY GUIDE". The FDA issued a decision of Substantially Equivalent on October 25, 1989. The device falls under product code HGL (Transducer, Ultrasonic, Obstetric), a Class II device regulated under 21 CFR 884.2960. Dymax Corp has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type

Other clearances by Dymax Corp

  • K032135 — SITE-RITE IV ULTRASOUND SYSTEM (July 21, 2003)
  • K993624 — SITE-RITE 3 ULTRASOUND SYSTEM (November 10, 1999)
  • K931403 — SITERITE NEEDLE GUIDE (MODIFIED) (July 27, 1993)
  • K903158 — SITERITE NEEDLE GUIDE (September 27, 1990)
  • K862127 — DYMAX PERSONAL SCANNER (December 11, 1986)
  • K850478 — PLUS 1 (April 15, 1985)

Other clearances for product code HGL

  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K924516 — OP3/VP4 (June 28, 1993)
  • K903348 — ULTRASONIC PULSED DOPPLER IMAGING SYSTEM (October 22, 1990)
  • K900966 — EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE (September 12, 1990)
  • K903316 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (August 22, 1990)
  • K901142 — MER MULTIPLANE VAGINAL PROBE (MVP) (August 22, 1990)
  • K900838 — TRANSVAGINAL TRANSDUCER ASSEMBLY (May 23, 1990)
  • K895449 — ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM (March 5, 1990)
  • K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (January 5, 1990)

FDA data resources