GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
FDA 510(k) clearance K173162 · decided 2018-06-28
Clearance details
- K-number
- K173162
- Device name
- GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-29
- Decision date
- 2018-06-28
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- PWJ
- Device class
- 2
- Regulation number
- 884.4910
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| ETHIZIA Hemostatic Patch (P240035/S001) | ETHICON, Inc. | 2026-01-22 |