Patchassist
FDA 510(k) K101218 · Polytouch Medical, Ltd.
510(k) numberK101218
Submission
- Device name
- Patchassist
- Applicant
- Polytouch Medical, Ltd.
Providence, RI, US - Received
- April 30, 2010
- Decision date
- June 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ORQ – Mesh, Surgical, Deployer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).
Other 510(k)s with product code ORQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250395 | BioBrace ® RC Delivery SystemORQ · Traditional | Conmed Corporation | 04/07/2025SE |
| K130782 | Accumesh Deployment SystemORQ · Special | Covidien, LLC | 04/05/2013SE |
| K123066 | Accumesh Deployment SystemORQ · Special | Covidien, LLC | 10/16/2012SE |
| K121139 | Accumesh Deployment SystemORQ · Special | Covidien, LLC | 05/02/2012SE |
| K103269 | Patchassist LargeORQ · Special | Polytouch Medical, Ltd. | 11/23/2010SE |
More from Polytouch Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K103269 | Patchassist LargeORQ · Special | 11/23/2010SE |
Questions and answers
When was Patchassist cleared by the FDA?
Patchassist (K101218) received a 510(k) decision of Substantially Equivalent on June 17, 2010, 48 days after the submission was received.
What is the product code of K101218?
The FDA product code is ORQ – Mesh, Surgical, Deployer, a Class II (moderate risk) device regulated under 21 CFR 878.3300.