Accumesh Deployment System
FDA 510(k) K130782 · Covidien, LLC
510(k) numberK130782
Submission
- Device name
- Accumesh Deployment System
- Applicant
- Covidien, LLC
Bedford, MA, US - Received
- March 21, 2013
- Decision date
- April 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| K250395 | BioBrace ® RC Delivery SystemORQ · Traditional | Conmed Corporation | 04/07/2025SE |
| 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 |
| K101218 | PatchassistORQ · Traditional | Polytouch Medical, Ltd. | 06/17/2010SE |
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Questions and answers
When was Accumesh Deployment System cleared by the FDA?
Accumesh Deployment System (K130782) received a 510(k) decision of Substantially Equivalent on April 5, 2013, 15 days after the submission was received.
What is the product code of K130782?
The FDA product code is ORQ – Mesh, Surgical, Deployer, a Class II (moderate risk) device regulated under 21 CFR 878.3300.