Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CooperSurgical, Inc. — Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
261 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243799 | Fetal Pillow | CooperSurgical, Inc. | 2025-08-29 | 261 | 0 |
| K250438 | CooperSurgical Milex® Pessaries | CooperSurgical, Inc. | 2025-04-11 | 56 | 0 |
| K223064 | ALLY II Uterine Positioning System™ (UPS) | CooperSurgical, Inc. | 2022-10-28 | 28 | 0 |
| K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2020-05-21 | 28 | 0 |
| K200038 | Endosee System | CooperSurgical, Inc. | 2020-02-05 | 28 | 0 |
| K191020 | G210 InviCell Plus with SignipHy pH monitoring | CooperSurgical, Inc. | 2020-01-14 | 272 | 0 |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019-06-12 | 29 | 0 |
| K190639 | Endosee System | CooperSurgical, Inc. | 2019-05-15 | 63 | 0 |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019-05-10 | 197 | 0 |
| K183020 | Endosee System | CooperSurgical, Inc. | 2019-01-31 | 91 | 0 |
| K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2018-03-14 | 26 | 0 |
| K173731 | SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrif | CooperSurgical, Inc. | 2018-03-02 | 86 | 0 |
| K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017-07-13 | 132 | 0 |
| K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit | CooperSurgical, Inc. | 2017-04-04 | 36 | 0 |
| K151845 | Infant Heel Warmer (Model 24401) and WarmGel Infant Heel War | CooperSurgical, Inc. | 2016-03-18 | 255 | 0 |
| K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | 2015-12-21 | 56 | 0 |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2015-07-21 | 210 | 0 |
| K143415 | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | 2015-02-26 | 90 | 0 |
| K141523 | ALLY UPS | CooperSurgical, Inc. | 2014-11-25 | 169 | 1 |
| K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | CooperSurgical, Inc. | 2014-10-23 | 211 | 0 |
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING D | CooperSurgical, Inc. | 2008-01-23 | 456 | 3 |
| K021237 | COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS | CooperSurgical, Inc. | 2003-04-10 | 357 | 0 |
| K023930 | COOPERSURGICAL OOCYTE RECOVERY NEEDLES | CooperSurgical, Inc. | 2003-01-22 | 58 | 0 |
| K990348 | WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N | CooperSurgical, Inc. | 1999-07-26 | 171 | 0 |
| K990349 | WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEAB | CooperSurgical, Inc. | 1999-07-26 | 171 | 6 |
| K990350 | WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, | CooperSurgical, Inc. | 1999-07-26 | 171 | 6 |
| K990852 | COOPERSURGICAL INFRARED COAGULATOR | CooperSurgical, Inc. | 1999-06-11 | 88 | 0 |
| K990850 | COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL | CooperSurgical, Inc. | 1999-06-01 | 78 | 0 |
| K990855 | COOPERSURGICAL INFRARED COAGULATOR FOR ENT | CooperSurgical, Inc. | 1999-03-30 | 15 | 0 |
| K972630 | COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM | CooperSurgical, Inc. | 1998-02-02 | 203 | 0 |
| K971836 | VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR | CooperSurgical, Inc. | 1997-11-07 | 172 | 0 |
| K971838 | MICRO ELECTRODES | CooperSurgical, Inc. | 1997-11-05 | 170 | 0 |
| K971837 | VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR | CooperSurgical, Inc. | 1997-08-06 | 79 | 0 |
| K954311 | KOH COLPOTOMIZER SYSTEM | CooperSurgical, Inc. | 1996-11-19 | 431 | 0 |
| K951898 | VERSA-VU | CooperSurgical, Inc. | 1995-12-11 | 231 | 0 |
| K952483 | LEEP SYSTEM 1000 | CooperSurgical, Inc. | 1995-10-06 | 129 | 0 |
| K914108 | RG27-SERIES RESECTOSCOPE AND ACCESSORIES | CooperSurgical, Inc. | 1992-03-19 | 188 | 0 |
| K910377 | COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM | CooperSurgical, Inc. | 1991-04-19 | 80 | 0 |
| K910254 | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) | CooperSurgical, Inc. | 1991-04-18 | 86 | 0 |
| K910253 | LEEP REDIKIT | CooperSurgical, Inc. | 1991-04-18 | 86 | 2 |
| K910252 | POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE | CooperSurgical, Inc. | 1991-03-04 | 41 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda