MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture— 510(k) K253852
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K253852 for MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture, Substantially Equivalent on 2026-02-06. Applicant: ETHICON, Inc.. Device class: 2.
Summary
Ethicon filed MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). The record doesn't describe the suture beyond its name and that code name.
Class II, 21 CFR 878.4493. General, 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. The substantially equivalent decision came 66 calendar days after receipt (December 2, 2025 to February 6, 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
Recent devices under product code GAM
view all- K263073 — Fast Absorbing PGLA
- K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- K253530 — Trexon Monofilament Synthetic Absorbable Suture
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K253620 — TroClose 1200
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.