ClearanceBrief
510(k) K904774 ยท HHW Pessary, Vaginal

INGLAT-O-BALL

ApplicantMilex Products, Inc., Chicago IL, US
DecisionSubstantially Equivalent, Dec 7, 1990
ReceivedOct 22, 1990
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K904774

DateFirm and productCodeLinked 510(k)
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06
Open, Classified
HHWNone listed
Feb 26, 2021CooperSurgical, 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
HHWNone listed
Apr 10, 2017CooperSurgical, 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
HHWNone listed
Nov 10, 2015CooperSurgical, 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
HHWNone listed
Nov 13, 2014CooperSurgical, 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
HHWNone listed
Nov 13, 2014CooperSurgical, 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed
Mar 27, 2013Cooper 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
HHWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.