# Ethicon, LLC. (manufacturer, San Lorenzo, PR): 1 new FDA device listing, incl. suture, absorbable, synthetic, polyglycolic acid

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Ethicon, LLC. |
| Owner / operator | Ethicon Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | San Lorenzo, PR, US |
| New listings | 1 |
| Devices | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Product codes | GAM |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery |
| Brand names | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices |
| First new listing | 2026-06-02 |
| Latest new listing | 2026-06-02 |
| FDA registration number | 2648650 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.