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510(k) K972013

NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS by National Healthcare Mfg. Corp. — Product Code KNA

K972013 is an FDA 510(k) premarket notification submitted by National Healthcare Mfg. Corp. for the device "NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. National Healthcare Mfg. Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
May 30, 1997
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 Healthcare Mfg. Corp.

  • K971465 — NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (June 4, 1997)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K962670 — NHMC IRRIGATION TRAY (August 14, 1996)
  • K962254 — NHMC URETHRAL CATHETERIZATION TRAY (July 29, 1996)
  • K960523 — NHMC DRESSING TRAY (April 4, 1996)
  • K960566 — NHMC FOLEY CATHETERIZATION TRAY (February 29, 1996)

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