510(k) K252318 ยท HIF Insufflator, Laparoscopic
Insufflator (OPTO-IFL1000)
| Applicant | Guangdong Optomedic Technologies, Inc., Foshan, CN |
| Decision | Substantially Equivalent, Apr 16, 2026 |
| Received | Jul 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252318
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.