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510(k) K882404

KEVOR-CURETTE by Euro-Med Intl. — Product Code PCF

K882404 is an FDA 510(k) premarket notification submitted by Euro-Med Intl. for the device "KEVOR-CURETTE". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code PCF (Sampler, Endocervical), a Class II device regulated under 21 CFR 884.1050. Euro-Med Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
June 10, 1988
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 Euro-Med Intl.

  • K883884 — PROSTATIC CORE-CUT NEEDLE (December 5, 1988)
  • K854901 — PACIFIC GRASPER (May 2, 1986)
  • K854898 — ATLANTIC GRASPER (May 2, 1986)
  • K854896 — HOOK SCISSOR (May 2, 1986)
  • K854894 — SPOON (May 2, 1986)
  • K854890 — HOOK PROBE (May 2, 1986)
  • K854895 — BASKET FORCEP (May 2, 1986)
  • K854891 — KNIFE (May 2, 1986)
  • K854897 — MAX-I-GRASP (May 2, 1986)
  • K854889 — FLEX-I-GRASP (February 21, 1986)

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

FDA data resources