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510(k) K161106

PANPAC DISPOSABLE VACUUM CURETTES by Panpac Medical Corporation — Product Code HGH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2017
Date Received
April 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Suction, Uterine
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

Other clearances by Panpac Medical Corporation

  • K173351 — Panpac Flexi Shelf Pessary (October 31, 2018)
  • K153422 — Panpac Disposable Pessary Fitting Set (July 14, 2016)
  • K132670 — PANPAC INFLATABLE DOCUT PESSARY (June 4, 2014)
  • K130087 — PANPAC WORD/BARTHOLIN CATHETER (January 10, 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 HGH

  • K172151 — Hysteroscopy System (April 9, 2018)
  • K140213 — DISPOSABLE ENDOSCOPIC CANNULA (March 25, 2015)
  • K093508 — RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) (March 4, 2010)
  • K935820 — KOLSTER METHODS (July 19, 1994)
  • K840285 — NON STRESS TEST MONITOR 507 (May 9, 1984)