Company · US
Cooper Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
30recalls (0 in 12 months)
17recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 13 |
| HHW | Pessary, Vaginal | 10 |
| MQF | Catheter, Assisted Reproduction | 4 |
| HDB | Extractor, Vacuum, Fetal | 3 |
| KGI | Densitometer, Bone | 2 |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 |
| HDW | Diaphragm, Contraceptive (And Accessories) | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 20, 2026 | K253698 | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Cooper Surgical | HHW |
| Jun 29, 2009 | K091325 | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS Cooper Surgical | KGI |
| Dec 20, 2002 | K023382 | COOPERSURGICAL MALLEABLE SYTLET Cooper Surgical | MQF |
| Dec 13, 2002 | K023384 | COOPERSURGICAL TRIAL TRANSFER CATHETER Cooper Surgical | MQF |
| Dec 13, 2002 | K023383 | COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER Cooper Surgical | MQF |
| Dec 11, 2002 | K023379 | COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER Cooper Surgical | MQF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2013 | Cooper Surgical, Inc. LEEP REDIKIT Product No. 6060
In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Terminated |
MQB | K910253 |
| Mar 28, 2013 | Cooper Surgical, Inc. Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65
Intended for use in contraception. Terminated |
HDW | K063223 |
| 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 | K904026 K904774 |
| 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 | K904026 K904774 |
| 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 | K904026 K904774 |
| 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 | K904026 K904774 |
| 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 | K904026 K904774 |
| 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 | K904026 K904774 |
| 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 | K904026 K904774 |
| 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 | K904026 K904774 |
| 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 | K904026 K904774 |
| Nov 26, 2012 | Cooper Surgical, Inc. Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle
Ref: UMH750
The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where posi Terminated |
LKF | K932115 |
| Nov 26, 2012 | Cooper Surgical, Inc. Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle
Ref: UMH700
The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning Terminated |
LKF | K932115 |
| Nov 18, 2011 | Cooper Surgical, Inc. DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers.
The XR 46 performs DXA scans of the Terminated |
KGI | K992125 |
| Oct 29, 2009 | Cooper Surgical, Inc. WA 1000 A/B Console
Model: 900516x. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. WA 4000 Console
Model: 900509x. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. WA 1000A with Blank Console
Model: 900506x. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 System
Model: 900107. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer No Connector CO2 System
Model: 900047. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 System
Model: 900043. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer Atom CO2 System
Model: 900036. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System
Model: 900034. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer No Gas Fitting CO2 System
Model: 900019x. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL50x Cryosurgical Freezer CO2 Unpinned Yoke System
Model: 900010. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL50x Cryosurgical Freezer CO2 System
Model: 900007. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 System
Model: 9000002X. Terminated |
GEH | None listed |
| Oct 29, 2009 | Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2
Model: 900000. Terminated |
GEH | None listed |
| Sep 17, 2008 | Cooper Surgical, Inc. Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vagina Terminated |
HDB | K011532 |
| Sep 17, 2008 | Cooper Surgical, Inc. M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery of an infant during c Terminated |
HDB | K011532 |
| Sep 17, 2008 | Cooper Surgical, Inc. M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use Terminated |
HDB | K011532 |