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510(k) K060320

FEMECC ENDOCERVICAL CURETTE by Femspec LLC — Product Code PCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2006
Date Received
February 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sampler, Endocervical
Device Class
Class II
Regulation Number
884.1050
Review Panel
OB
Submission Type

Obtains tissue samples from the endocervical canal for histological analysis.

Other clearances by Femspec LLC

  • K052192 — FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I (February 2, 2006)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)
  • K041757 — FEMSPEC DISPOSABLE VAGINAL SPECULUM (December 23, 2004)

Other clearances for product code PCF

  • K122658 — FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-00 (December 20, 2012)
  • K882606 — EURO-MED ENDO-CURETTE (July 25, 1988)
  • K882404 — KEVOR-CURETTE (July 8, 1988)
  • K860796 — DISPO-URETTE (April 8, 1986)