ClearanceBrief
510(k) K904026 ยท HHW Pessary, Vaginal

INFLAT-O-BALL

ApplicantMilex Products, Inc., Chicago IL, US
DecisionSubstantially Equivalent, Oct 10, 1990
ReceivedAug 30, 1990
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K904026

DateFirm and productCodeLinked 510(k)
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
Mar 3, 2015CooperSurgical, Inc.
CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
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.