510(k) K964276
- Device
- ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR
- Applicant
- RICHARD WOLF MEDICAL INSTRUMENTS CORP.
- 510(k) number
- K964276
- Product code
- HEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-11-25
- Date received
- 1996-10-28
- Regulation
- 884.1640
- Classification name
- Culdoscope (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT L CASARSA
- Address
- 353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061
FDA Registration Numbers#
- 1320468
- 3012783431
- 9611102
- 1836161
- 2528981
- 1418479
- 1519132
- 1216677
- 2246552
- 3003790304
- 3008693678
- 3011050570
- 2027111
- 8030607
- 1627186
- 3010202439
- 2020550
- 3009051888
- 3007156625
- 3009763019
- 2032098
- 3008254127
Source Documents#
Other 510(k) Records For Product Code HEW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp. | 2025-10-02 |
| K201086 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2020-05-21 |
| K191294 | Transvaginal Access Platform | Applied Medical Resources Corp. | 2019-09-06 |
| K180429 | Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2018-03-14 |
| K161065 | ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator | Surgitools Pty , Ltd. | 2016-10-27 |
| K143308 | GelPOINT Transvaginal Access Platform | Applied Medical Resources | 2015-10-13 |
| K143650 | CooperSurgical Advincula Delineator Uterine Manipulator | CooperSurgical, Inc. | 2015-07-21 |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | Lsi Solutions, Inc. | 2012-07-13 |
| K110819 | SINGHMED ROOLIP MANIPULATOR | J.Singh Instruments | 2011-10-05 |
| K051160 | MANIPUSEAL | Insitu Systems | 2005-09-02 |
| K051594 | MCCARTNEY ACCESS TUBE | Gynetech Pty. , Ltd. | 2005-09-02 |
| K033728 | TRANSVAGINAL ENDOSCOPY SET | KARL STORZ Endoscopy-America, Inc. | 2004-02-27 |
| K992655 | FERTILOSCOPY KIT FH 1.29/FTO 1.40 | Soprane S.A. | 2000-03-13 |
| K993804 | KSEA RIGID CULDOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2000-02-07 |
| K980972 | RIGID CULDOSCOPE AND ACCESSORIES | Circon Corp. | 1998-06-12 |
Legacy Summary#
summary
FDA Review#
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