Home / 510(k) Clearances / K870550

510(k) K870550

TEFLON UTERINE SOUND by Cook Ob/Gyn — Product Code HHM

K870550 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "TEFLON UTERINE SOUND". The FDA issued a decision of Substantially Equivalent on Mar 4, 1987. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. Cook Ob/Gyn has 42 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 4, 1987
Date Received
Feb 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Sound, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type
510(k) Exempt

Other clearances by Cook Ob/Gyn

  • K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 (Oct 27, 2006)
  • K030441 — SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT (Aug 29, 2003)
  • K023850 — SYDNEY IVF EMBRYO BIOPSY MEDIUM (Jan 22, 2003)
  • K013597 — TAMPONADE UTERINE BALLOON CATHETER SET (Apr 17, 2002)
  • K002385 — COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF… (Sep 18, 2000)
  • K002383 — COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT (Sep 13, 2000)
  • K983595 — TRANSMYOMETRIAL EMBRYO TRANSFER SET (Feb 8, 1999)
  • K983596 — INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING… (Feb 5, 1999)
  • K983642 — COOK MINI-INCUBATOR (Feb 1, 1999)
  • K983593 — OVUM PICK-UP ASPIRATION NEEDLES (Jan 21, 1999)

Other clearances for product code HHM

  • K011840 — CERVILENZ UTERINE MEASURING SOUND (Aug 10, 2001)
  • K935665 — INTRAUTERINE SOUND (Feb 24, 1994)
  • K884684 — ROCKET INTRAUTERINE DEPTH SOUND (Dec 20, 1988)
  • K883806 — ROCKET INTRAUTERINE SOUND (Oct 31, 1988)
  • K840380 — UTERINE SOUND (Apr 30, 1984)
  • K831224 — AUGROS HYSTEROMETER (Oct 28, 1983)
  • K802315 — UTERINE SOUND (Jan 12, 1981)
  • K781766 — UTERINE SOUND, BURNETT DISPOSABLE (Dec 7, 1978)
  • K760170 — INTRAUTERINE SOUND, PLASTIC DISPOSABLE (Jul 19, 1976)

FDA data resources

Source: FDA 510(k) database entry for K870550. Report a data issue: hello@regdatalab.com.