Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HEW — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
195 daysmedian FDA review time
431 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperit | Applied Medical Resources Corp. | 2025-10-02 | 367 | 0 |
| K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2020-05-21 | 28 | 0 |
| K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | 2019-09-06 | 115 | 0 |
| K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2018-03-14 | 26 | 0 |
| K161065 | ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator | Surgitools Pty , Ltd. | 2016-10-27 | 195 | 0 |
| K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | 2015-10-13 | 329 | 0 |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2015-07-21 | 210 | 0 |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESS | Lsi Solutions, Inc. | 2012-07-13 | 459 | 0 |
| K110819 | SINGHMED ROOLIP MANIPULATOR | J.Singh Instruments | 2011-10-05 | 196 | 0 |
| K051160 | MANIPUSEAL | Insitu Systems | 2005-09-02 | 120 | 0 |
| K051594 | MCCARTNEY ACCESS TUBE | Gynetech Pty. , Ltd. | 2005-09-02 | 78 | 0 |
| K033728 | TRANSVAGINAL ENDOSCOPY SET | KARL STORZ Endoscopy-America, Inc. | 2004-02-27 | 91 | 0 |
| K992655 | FERTILOSCOPY KIT FH 1.29/FTO 1.40 | Soprane S.A. | 2000-03-13 | 217 | 0 |
| K993804 | KSEA RIGID CULDOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2000-02-07 | 90 | 0 |
| K980972 | RIGID CULDOSCOPE AND ACCESSORIES | Circon Corp. | 1998-06-12 | 88 | 0 |
| K964276 | ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR | Richard Wolf Medical Instruments Corp. | 1997-11-25 | 393 | 0 |
| K954311 | KOH COLPOTOMIZER SYSTEM | CooperSurgical, Inc. | 1996-11-19 | 431 | 0 |
| K962881 | KSEA CULDOCENTESIS SET | Karl Storz Endoscopy | 1996-10-22 | 90 | 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