GelPOINT V-Path Vaginal Access System
FDA 510(k) clearance K220969 · decided 2022-09-16
Clearance details
- K-number
- K220969
- Device name
- GelPOINT V-Path Vaginal Access System
- Applicant
- Applied Medical Resources Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-04-04
- Decision date
- 2022-09-16
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- MOK
- Device class
- 2
- Regulation number
- 884.1630
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Rancho Santa, CA, 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 |
|---|---|---|
| KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS (K950639) | KARL STORZ Endoscopy-America, Inc. | 1995-06-19 |
Recalls involving this device
No recalls on record reference this clearance.