# Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230): 510(k) cleared for Suzhou Medical Appliance Factory

**Predicate Speed & CAPA Advisory Opportunity Score:** 67/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260230 |
| Device | Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) |
| Applicant | Suzhou Medical Appliance Factory |
| Specialty / panel | Other |
| Product code | BWK |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-26 |
| Decision date | 2026-10-22 |
| Review time (days) | 269 |
| Third-party review | No |
| Applicant location | Suzhou, CN |

## Why this score
- A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 13 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260230). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.