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510(k) K770727

MANIPULATOR & INJECTOR, UTERINE by National Catheter Co. Div. Mallinckrodt — Product Code KNA

K770727 is an FDA 510(k) premarket notification submitted by National Catheter Co. Div. Mallinckrodt for the device "MANIPULATOR & INJECTOR, UTERINE". The FDA issued a decision of Substantially Equivalent on April 26, 1977. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. National Catheter Co. Div. Mallinckrodt has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1977
Date Received
April 19, 1977
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 National Catheter Co. Div. Mallinckrodt

  • K802918 — ANTHRON CATHETER SET (April 21, 1981)
  • K802505 — DOUBLE LUMEN TRACHEAL TUBE (March 13, 1981)
  • K810321 — REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) (March 4, 1981)
  • K801924 — HI-LO TEMP GEN. PURPOSE TEMP. PROBE (September 9, 1980)
  • K801005 — MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) (May 23, 1980)
  • K791190 — STETHOSCOPE WITH TEMPERATURE SENSOR (July 6, 1979)
  • K781665 — TUBE, LEATHERMAN/IMBRUCE (December 15, 1978)

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