510(k) K896701

TEFLON CERVICAL ACCESS SET by Cook Ob/Gyn — Product Code HDQ

K896701 is an FDA 510(k) premarket notification submitted by Cook Ob/Gyn for the device "TEFLON CERVICAL ACCESS SET". The FDA issued a decision of Substantially Equivalent on September 13, 1990. The device falls under product code HDQ (Dilator, Cervical, Fixed Size), a Class I device regulated under 21 CFR 884.4530. Cook Ob/Gyn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 13, 1990
Date Received: November 28, 1989
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dilator, Cervical, Fixed Size
Device Class: Class I
Regulation Number: 884.4530
Review Panel: OB
Submission Type

Other clearances by Cook Ob/Gyn

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

510(k) K896701

Clearance Details

Device Classification

Other clearances by Cook Ob/Gyn

Other clearances for product code HDQ

FDA data resources