510(k) K904774 ยท HHW Pessary, Vaginal
INGLAT-O-BALL
| Applicant | Milex Products, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Dec 7, 1990 |
| Received | Oct 22, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904774
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4"
Catalog # MXPCON06 Open, Classified |
HHW | None listed |
| Feb 26, 2021 | CooperSurgical, Inc. Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2 Terminated |
HHW | None listed |
| Apr 10, 2017 | CooperSurgical, Inc. CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit.
Product Usage:
The lnflatoball Pessary is a single-patient use pessary manufac Terminated |
HHW | None listed |
| Nov 10, 2015 | CooperSurgical, Inc. MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07
Product Usage:
The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic su Terminated |
HHW | None listed |
| Nov 13, 2014 | CooperSurgical, Inc. CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1
Model: MXKPRS01
Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number o Terminated |
HHW | None listed |
| Nov 13, 2014 | CooperSurgical, Inc. CooperSurgical MILEX PESSARY KITS-
Hodge w/Support Folding Pessary- #1
Model: MXKPHS01
Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex
Part Number: MXPCON04
A pessary is a medical device that is inserted into the vagina to function as a supportive structure o Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex
:Part Number: MXPCONDS05
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of t Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex
Part Number: MXKPCONDS00
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of t Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex
Part Number: MXKPCOND00
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the u Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex
Part Number: MXPCOND00
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the ut Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex
Part Number: MXPGE2-3/4
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uter Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex
Part Number: MXPGE3-
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/o Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Cube Pessary 1 5/8"", 41mm.
Milex
Part Number: MXKPEC04
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or blad Terminated |
HHW | None listed |
| Mar 27, 2013 | Cooper Surgical, Inc. Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex
Part Number: MXKPECH00
A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the ute Terminated |
HHW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.