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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 Jul 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 15 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 8, 1988
Date Received
Jun 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
510(k)

Obtains tissue samples from the endocervical canal for histological analysis.

Other clearances by Euro-Med Intl.

  • K883884 — PROSTATIC CORE-CUT NEEDLE (Dec 5, 1988)
  • K854898 — ATLANTIC GRASPER (May 2, 1986)
  • K854891 — KNIFE (May 2, 1986)
  • K854897 — MAX-I-GRASP (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)
  • K854901 — PACIFIC GRASPER (May 2, 1986)
  • K854889 — FLEX-I-GRASP (Feb 21, 1986)

Other clearances for product code PCF

  • K122658 — FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF… (Dec 20, 2012)
  • K060320 — FEMECC ENDOCERVICAL CURETTE (Jul 28, 2006)
  • K882606 — EURO-MED ENDO-CURETTE (Jul 25, 1988)
  • K860796 — DISPO-URETTE (Apr 8, 1986)

FDA data resources