# Scientific Molding Corporation, Ltd. Dba Smc Ltd. (contract manufacturer, Santa Rosa, CA): 2 new FDA device listings, incl. probe, radiofrequency lesion

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Scientific Molding Corporation, Ltd. Dba Smc Ltd. |
| Owner / operator | Scientific Molding Corporation, Ltd |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Santa Rosa, CA, US |
| New listings | 2 |
| Devices | Probe, Radiofrequency Lesion; Left Atrial Appendage Clip, Implantable |
| Product codes | GXI, PZX |
| Device classes | Class II |
| Medical specialties | Neurology, General, Plastic Surgery |
| Brand names | Intracept RF Probe; Intracept Access Instruments; ECLIPTIS Left Atrial Appendage Exclusion System |
| First new listing | 2026-06-29 |
| Latest new listing | 2026-07-21 |
| FDA registration number | 3010034260 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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.