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510(k) K972210

RESECTOSCOPE SAFETY SHEATH by Conceptus, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1997
Date Received
June 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Conceptus, Inc.

  • K974028 — STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING (January 21, 1998)
  • K962587 — CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM (January 31, 1997)
  • K954164 — HYSTEROSCOPE (March 12, 1996)
  • K953314 — CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM (July 28, 1995)
  • K932387 — CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL (March 6, 1995)
  • K932993 — INTRAUTERINE CATHETER AND INTRODUCER (January 6, 1995)
  • K933723 — CONCEPTUS UTERINE CATHETER (December 27, 1994)
  • K933981 — CERVICAL CATHETER (December 27, 1994)

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