Panels › Obstetrics/Gynecology › Product code HEW · Class 2
Culdoscope (And Accessories)
Regulation 884.1640
0510(k)s in 12 months (18 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in HEW
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 4 | 4 |
| Applied Medical Resources | 3 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 0 |
| Circon Corp. | 1 | 0 |
| Gynetech Pty. , Ltd. | 1 | 0 |
| Insitu Systems | 1 | 0 |
| J.Singh Instruments | 1 | 0 |
| Karl Storz Endoscopy | 1 | 0 |
| Lsi Solutions, Inc. | 1 | 0 |
| Richard Wolf Medical Instruments Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2025 | K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device Applied Medical Resources Corp. | HEW |
| May 21, 2020 | K201086 | Advincula Delineator Uterine Manipulator CooperSurgical, Inc. | HEW |
| Sep 6, 2019 | K191294 | Transvaginal Access Platform Applied Medical Resources Corp. | HEW |
| Mar 14, 2018 | K180429 | Advincula Delineator Uterine Manipulator CooperSurgical, Inc. | HEW |
| Oct 27, 2016 | K161065 | ColpoWave Colpotomizer and CerviGrip Uterine Manipulator Surgitools Pty , Ltd., AU | HEW |
| Oct 13, 2015 | K143308 | GelPOINT Transvaginal Access Platform Applied Medical Resources | HEW |
| Jul 21, 2015 | K143650 | CooperSurgical Advincula Delineator Uterine Manipulator CooperSurgical, Inc. | HEW |
| Jul 13, 2012 | K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES Lsi Solutions, Inc. | HEW |
| Oct 5, 2011 | K110819 | SINGHMED ROOLIP MANIPULATOR J.Singh Instruments | HEW |
| Sep 2, 2005 | K051594 | MCCARTNEY ACCESS TUBE Gynetech Pty. , Ltd. | HEW |
| Sep 2, 2005 | K051160 | MANIPUSEAL Insitu Systems | HEW |
| Feb 27, 2004 | K033728 | TRANSVAGINAL ENDOSCOPY SET KARL STORZ Endoscopy-America, Inc. | HEW |
| Mar 13, 2000 | K992655 | FERTILOSCOPY KIT FH 1.29/FTO 1.40 Soprane S.A. | HEW |
| Feb 7, 2000 | K993804 | KSEA RIGID CULDOSCOPE AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. | HEW |
| Jun 12, 1998 | K980972 | RIGID CULDOSCOPE AND ACCESSORIES Circon Corp. | HEW |
| Nov 25, 1997 | K964276 | ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR Richard Wolf Medical Instruments Corp. | HEW |
| Nov 19, 1996 | K954311 | KOH COLPOTOMIZER SYSTEM CooperSurgical, Inc. | HEW |
| Oct 22, 1996 | K962881 | KSEA CULDOCENTESIS SET Karl Storz Endoscopy | HEW |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.