WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM— 510(k) K964848

Name: FDA 510(k) clearance K964848
Creator: U.S. Food and Drug Administration
Published: 1997-01-16

Substantially Equivalent

Marlow Surgical Technologies, Inc.

FDA 510(k) clearance K964848 for WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM, Substantially Equivalent on 1997-01-16. Applicant: Marlow Surgical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Marlow Surgical Technologies, Inc.
Product code: Code MFD
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 1996-12-03
Decision date: 1997-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willoughby, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MFD

view all

K021438 — INSEMINATION CATHETER, MODEL 3203012002-07-16
K012935 — THECURVE, ITEM 5072001-10-11
K984306 — `THE INSEMINATOR' (PROPOSED)1999-03-01
K982630 — MEDWORKS VISUALIZATION INSEMINATION CATHETER1999-01-14
K982628 — MEDWORKS INSEMINATION CATHETER1998-08-21

More clearances from Marlow Surgical Technologies, Inc.

view all

K944563 — FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS1994-12-27

Recalls naming K964848

K-number listed on FDA's recall record

Z-1713-2020 — Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.Class III·Terminated·CooperSurgical, Inc.·20200228

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964848.

Data sourced from openFDA. This site is unofficial and independent of the FDA.