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510(k) K990045

BERACLAMP, MODEL BC-1 by Poamax LLC — Product Code KNA

K990045 is an FDA 510(k) premarket notification submitted by Poamax LLC for the device "BERACLAMP, MODEL BC-1". The FDA issued a decision of Substantially Equivalent on May 24, 1999. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1999
Date Received
January 6, 1999
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

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  • 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