ECHOMARK INTRAUTERINE GUIDING CATHETER
FDA 510(k) clearance K932436 · decided 1995-11-16
Clearance details
- K-number
- K932436
- Device name
- ECHOMARK INTRAUTERINE GUIDING CATHETER
- Applicant
- Echocath, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-19
- Decision date
- 1995-11-16
- Days to decision
- 911 days
- Clearance type
- Traditional
- Product code
- MOV
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Princeton, 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.
| Record | Firm | Date |
|---|---|---|
| Modified Novy Cornual Cannulation Set (K180552) | Cook Incorporated | 2018-07-12 |
| OVAMED INTRAUTERINE ACCESS CATHETER (K931534) | Ovamed Corp. | 1995-07-28 |
| NOVY CORNUAL CANNULATION SET (K931476) | Cook Ob/Gyn | 1995-07-28 |
| CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM (K953314) | Conceptus, Inc. | 1995-07-28 |
Recalls involving this device
No recalls on record reference this clearance.