Apyx
FDA 510(k) clearance K230730 · decided 2023-07-25
Clearance details
- K-number
- K230730
- Device name
- Apyx
- Applicant
- Escala Medical
- Decision
- Substantially Equivalent
- Date received
- 2023-03-16
- Decision date
- 2023-07-25
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- PBQ
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Misgav, IL
- 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 |
|---|---|---|
| Mendit (K260380) | Escala Medical, Ltd. | 2026-03-04 |
| Saffron Fixation System (K220420) | Coloplast A/S | 2022-06-10 |
| Apyx (K213783) | Escala Medical | 2022-04-05 |
| NeuGuide (K160569) | Pop Medical Solutions | 2016-07-06 |
| ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP (K130059) | Ibi Israel Biomedical Innovations , Ltd. | 2013-07-29 |
| ANCHORSURE (K120831) | Neomedic International S.L. | 2012-10-12 |
| GYNECARE PROLENE FASTENER SYSTEM (K042603) | ETHICON, Inc. | 2004-12-22 |
Recalls involving this device
No recalls on record reference this clearance.