Polyglycolic Acid Suture, Absorbable, Synthetic
by Trading Consultants and Distributors Intl., Inc.
510(k) K994001
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK994001 | Date9 Feb 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Polyglycolic Acid
- 510(k) Number
- FDA Product Code
- GAM
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4493
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is an absorbable, synthetic suture classified under the FDA’s Device Class II. Polyglycolic acid sutures are designed to approximate and ligate soft tissues during surgical procedures. They are biodegradable, gradually breaking down and being absorbed by the body over time, reducing the need for suture removal.
The suture is supplied in sterile, single-use packaging and is intended for use in general and plastic surgery settings. It is non-magnetic and MRI-safe, allowing for compatibility with magnetic resonance imaging. Available in various sizes and lengths, it is stored under controlled conditions to maintain sterility and integrity until use. The device holds an FDA 510(k) clearance under the classification GAM (General and Plastic Surgery Materials).
Other devices from Trading Consultants and Distributors Intl., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is polyglycolic acid suture used for?
Polyglycolic acid suture is designed to approximate and ligate soft tissues during surgical procedures. Its biodegradable nature allows it to gradually break down and be absorbed by the body, eliminating the need for suture removal. This makes it particularly useful in general and plastic surgery settings where tissue healing and minimal intervention are priorities.
How is this suture supplied and what does sterile single-use mean?
The suture is supplied in sterile, single-use packaging, meaning each package is intended for one surgical procedure only. Sterility ensures no contamination occurs before use, reducing infection risks. The controlled packaging maintains integrity until the moment of use, ensuring the suture remains uncontaminated and ready for surgical application.
Is this suture safe for MRI procedures?
Yes, this polyglycolic acid suture is non-magnetic and MRI-safe. This means it can be used in patients who require magnetic resonance imaging (MRI) without interfering with the imaging process or posing risks during the scan. Its compatibility with MRI ensures it won’t distort images or cause complications during diagnostic procedures.
What sizes and models are available for this suture?
This suture is available in various sizes and lengths, tailored to meet different surgical needs. The exact specifications (e.g., gauge, length, or packaging configurations) are not detailed here, but the manufacturer provides multiple options to accommodate general and plastic surgery applications. For precise sizing requirements, refer to the product documentation or contact the manufacturer directly.
How should this suture be stored to maintain sterility and integrity?
To preserve sterility and integrity, this suture must be stored under controlled conditions as specified by the manufacturer. Typically, this includes keeping it in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. The sealed packaging should remain unopened until use, and any exposed or compromised packaging should be discarded to prevent contamination.