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510(k) K092982

THE PANPAC SUCTION CURETTE by Panpac Medical Corporation — Product Code HHK

K092982 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "THE PANPAC SUCTION CURETTE". The FDA issued a decision of Substantially Equivalent on July 26, 2010. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2010
Date Received
September 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Suction, Endometrial (And Accessories)
Device Class
Class II
Regulation Number
884.1175
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)
  • 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)
  • 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 HHK

  • K251882 — Uterine Aspiration Set (October 16, 2025)
  • K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (September 25, 2024)
  • K201952 — CrossGlide ETS Plus (August 5, 2020)
  • K192534 — CrossBay Endometrial Tissue Sampler (ETS) (March 25, 2020)
  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (April 14, 2011)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 2004)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (April 8, 2003)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)

FDA data resources