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510(k) K122658

FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 by Femasys, Inc. — Product Code PCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2012
Date Received
August 31, 2012
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.

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Other clearances for product code PCF

  • K060320 — FEMECC ENDOCERVICAL CURETTE (July 28, 2006)
  • K882606 — EURO-MED ENDO-CURETTE (July 25, 1988)
  • K882404 — KEVOR-CURETTE (July 8, 1988)
  • K860796 — DISPO-URETTE (April 8, 1986)