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510(k) K941641

DISPOSABLE EMERGENCY OBSTETRICAL KIT by Gam Industries, Inc. — Product Code KNA

K941641 is an FDA 510(k) premarket notification submitted by Gam Industries, Inc. for the device "DISPOSABLE EMERGENCY OBSTETRICAL KIT". The FDA issued a decision of Substantially Equivalent on October 3, 1994. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. Gam Industries, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
April 4, 1994
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 Gam Industries, Inc.

  • K941336 — COMBO MASK (September 9, 1994)
  • K942021 — MOUTH TO MOUTH BREATHER (June 22, 1994)
  • K936050 — JAW SPREADER (March 24, 1994)
  • K930401 — ALUMINUM FOIL (May 12, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K915569 — UMBILICAL CLAMP (September 23, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)

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