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510(k) K861385

MILEX BARTHOLIN GLAND CATHETER by Milex Products, Inc. — Product Code KNA

K861385 is an FDA 510(k) premarket notification submitted by Milex Products, Inc. for the device "MILEX BARTHOLIN GLAND CATHETER". The FDA issued a decision of Substantially Equivalent on June 16, 1986. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. Milex Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1986
Date Received
April 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Milex Products, Inc.

  • K001545 — PIPET CURET (June 15, 2000)
  • K904774 — INGLAT-O-BALL (December 7, 1990)
  • K904026 — INFLAT-O-BALL (October 10, 1990)
  • K900903 — KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE (May 3, 1990)
  • K882628 — ENDO C BRUSH (July 25, 1988)
  • K862410 — MILEX KEGEL PERINEAL EXERCISER (July 31, 1986)
  • K760264 — CURETTE, PROPOSED TIS-U-TRAP, METAL (October 6, 1976)

Other clearances for product code KNA

  • K130087 — PANPAC WORD/BARTHOLIN CATHETER (January 10, 2014)
  • K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) (May 6, 2011)
  • K093904 — GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (April 14, 2010)
  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (September 3, 2009)
  • K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (October 27, 2006)
  • K060289 — EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 (July 7, 2006)
  • K013597 — TAMPONADE UTERINE BALLOON CATHETER SET (April 17, 2002)
  • K014248 — DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (March 21, 2002)
  • K001590 — DND 101 (August 2, 2000)
  • K990738 — DR. JAHANGER'S CUTTER (October 29, 1999)

FDA data resources