510(k) K101218
- Device
- PATCHASSIST
- Applicant
- POLYTOUCH MEDICAL LTD
- 510(k) number
- K101218
- Product code
- ORQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-06-17
- Date received
- 2010-04-30
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Deployer
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEO BASTA
- Address
- 755 Westminster St. Unit 120 Providence RI US 02903 02903
FDA Registration Numbers#
- 3016678045
- 3003604053
- 3012358417
- 3021632375
- 1219930
- 3005636544
- 3027448274
- 2246552
- 3013188547
- 3010273872
- 3006082230
- 2249852
- 1213643
- 3018094310
- 1017294
Source Documents#
Other 510(k) Records For Product Code ORQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250395 | BioBrace ® RC Delivery System | Conmed Corporation | 2025-04-07 |
| K130782 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2013-04-05 |
| K123066 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2012-10-16 |
| K121139 | ACCUMESH DEPLOYMENT SYSTEM | Covidien, LLC | 2012-05-02 |
| K103269 | PATCHASSIST LARGE | Polytouch Medical, Ltd. | 2010-11-23 |
Legacy Summary#
summary
FDA Review#
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