Home / 510(k) Clearances / K130087

510(k) K130087

PANPAC WORD/BARTHOLIN CATHETER by Panpac Medical Corporation — Product Code KNA

K130087 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "PANPAC WORD/BARTHOLIN CATHETER". The FDA issued a decision of Substantially Equivalent on January 10, 2014. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2014
Date Received
January 14, 2013
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 Panpac Medical Corporation

  • K173351 — Panpac Flexi Shelf Pessary (October 31, 2018)
  • K161106 — PANPAC DISPOSABLE VACUUM CURETTES (January 13, 2017)
  • K153422 — Panpac Disposable Pessary Fitting Set (July 14, 2016)
  • K132670 — PANPAC INFLATABLE DOCUT PESSARY (June 4, 2014)
  • K130273 — PANPAC VAGINAL DILATORS (August 8, 2013)
  • K102898 — BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY (December 15, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K092981 — PANPAC VAGINAL PESSARY (July 22, 2010)
  • K092983 — PANPAC HSG CATHETER SET (June 7, 2010)
  • K092984 — PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 (April 7, 2010)

Other clearances for product code KNA

  • 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)
  • K990045 — BERACLAMP, MODEL BC-1 (May 24, 1999)

FDA data resources