Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture— 510(k) K253394
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K253394 for Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture, Substantially Equivalent on 2026-06-25. Applicant: ETHICON, Inc.. Device class: 2.
Summary
ETHICON's Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture is filed under GAM, synthetic absorbable polyglycolic acid sutures. The polyglactin 910 material and the antibacterial label come from the device name; the record gives no sizes.
Class II, 21 CFR 878.4493. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ethicon filed from Raritan, New Jersey. Review took 268 calendar days (September 30, 2025 to June 25, 2026).
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Product code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
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- K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
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More clearances from ETHICON, Inc.
view all- K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
- K221744 — STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
Adverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.