Monoswift
FDA 510(k)FDA UDIClass II (US FDA 510(k))
by Cp Medical
Identity
- Trade Name
- MONOSWIFT FDA UDI
- Generic Name
- Polyglyconate suture FDA UDI
- Model / Reference
- L463 FDA UDI
Identifiers
- Catalog Number
- L463 FDA UDI
- Primary DI / UDI-DI
- 10790986001388 FDA UDI
- 510(k) Number
- FDA Product Code
- GAM FDA 510(k)FDA UDI
- GMDN Term
- Polyglyconate suture FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4493 FDA 510(k)
- Regulation Number
- 878.4493 FDA 510(k)FDA UDI
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Monoswift is a synthetic absorbable suture made of polyglycolic acid. It is classified as a suture device under FDA product code GAM and regulation number 878.4493.
The device received FDA 510(k) clearance (K072229) on October 5, 2007, and is substantially equivalent to a predicate device. It is intended for use in general and plastic surgery procedures.
Frequently asked questions
What is Monoswift used for?
Monoswift is intended for use in general and plastic surgery procedures as a synthetic absorbable suture made of polyglycolic acid, providing temporary wound support until healing occurs.
How is Monoswift supplied and is it sterile?
Monoswift is supplied as a sterile suture device, though specific packaging details are not provided in the authorization data; sterility is implied by its FDA 510(k) clearance for surgical use.
Is Monoswift reusable or single-use?
Monoswift is a single-use device, as it is an absorbable suture designed to be implanted and gradually broken down in the body, making reuse unsafe and ineffective.
What regulatory pathway was used for Monoswift?
Monoswift received FDA 510(k) clearance (K072229) on October 5, 2007, demonstrating substantial equivalence to a predicate device under product code GAM and regulation 878.4493.
What material is Monoswift made from and what class is it?
Monoswift is made of polyglycolic acid, a synthetic absorbable polymer, and is classified as a Class II medical device under FDA product code GAM for sutures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072229 | Class II | Active |
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Manufacturer
- Manufacturer
- Cp Medical
Sources (2)
- FDA 510(k) K072229 24 fields · synced Sep 23, 2026
- FDA UDI b9633842-cb99-45f0-ba56-86b8eee31f90 34 fields · synced May 26, 2026