Maxon Polyglyconate Monofilament Absorbable Suture
by Davis & Geck, Inc. PMA
Active
PMA P840051
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP840051 | Date7 Jun 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Maxon(Tm) Polyglyconate Monofilament Absorbable Su
- Generic Name
- Suture, absorbable, synthetic, polyglycolic acid
- PMA Number
- FDA Product Code
- GAM
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4493
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APPR Approved
- PMA Supplement
- S003 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Maxon Polyglyconate Monofilament Absorbable Suture is a synthetic, absorbable suture classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid. It is designed for use in general and plastic surgery procedures, providing a durable yet biodegradable option for tissue approximation and wound closure. The monofilament construction reduces tissue drag and infection risk, while its absorbable nature ensures gradual resorption by the body over time.
This suture is supplied sterile and intended for single-use in surgical settings. It is non-magnetic and MRI-safe, making it suitable for use in environments requiring imaging compatibility. Available in various sizes, it is stored under controlled conditions to maintain sterility and integrity until use. The device holds an FDA Premarket Approval (PMA) designation under PMA number P840051, with regulatory oversight under classification GAM and regulation number 878.4493.
Other devices from Davis & Geck, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures is the Maxon Polyglyconate Monofilament Absorbable Suture typically used for?
The Maxon Polyglyconate Monofilament Absorbable Suture is designed for use in general and plastic surgery procedures. Its monofilament construction and absorbable nature make it suitable for tissue approximation and wound closure in these specialized fields, where durability and biocompatibility are important.
Is this suture safe to use in patients who require MRI scans, and why?
Yes, the Maxon Polyglyconate Monofilament Absorbable Suture is non-magnetic and MRI-safe, which means it can be used in patients who require magnetic resonance imaging without interference or safety concerns.
How should the Maxon Polyglyconate Monofilament Absorbable Suture be stored to maintain its integrity?
The suture is supplied sterile and must be stored under controlled conditions to preserve sterility and integrity until use. Proper storage ensures it remains effective for its intended single-use application in surgical settings.
Are there multiple sizes available for the Maxon Polyglyconate Monofilament Absorbable Suture, and how does this benefit clinicians?
Yes, the Maxon Polyglyconate Monofilament Absorbable Suture is available in various sizes. This versatility allows clinicians to select the appropriate suture size for different tissue types and surgical needs, ensuring optimal wound closure and tissue approximation.
Can this suture be reused, or is it intended for single-use only?
The Maxon Polyglyconate Monofilament Absorbable Suture is explicitly intended for single-use in surgical settings. Its sterile packaging and absorbable nature make reuse unsafe and unsuitable for clinical practice.