PATCHASSIST
FDA 510(k) clearance K101218 · decided 2010-06-17
Clearance details
- K-number
- K101218
- Device name
- PATCHASSIST
- Applicant
- Polytouch Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-30
- Decision date
- 2010-06-17
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- ORQ
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Providence, RI, 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 |
|---|---|---|
| BioBrace ® RC Delivery System (K250395) | Conmed Corporation | 2025-04-07 |
| ACCUMESH DEPLOYMENT SYSTEM (K130782) | Covidien, LLC | 2013-04-05 |
| ACCUMESH DEPLOYMENT SYSTEM (K123066) | Covidien, LLC | 2012-10-16 |
| ACCUMESH DEPLOYMENT SYSTEM (K121139) | Covidien, LLC | 2012-05-02 |
| PATCHASSIST LARGE (K103269) | Polytouch Medical, Ltd. | 2010-11-23 |
Recalls involving this device
No recalls on record reference this clearance.