FDA applicant
Snowden-Pencer
FDA records 11 decisions for Snowden-Pencer (Tucker, GA) from 1986 to 2003: 11 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HIF (Insufflator, Laparoscopic). Its devices cite 4 predicates, 2 of them its own earlier devices. 15 recalls are linked to its devices.
FDA’s records also spell it “Snowden Pencer, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Snowden-Pencer’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Snowden-Pencer since 2007.
Recalls per year
15in 2023
Class I Class II/III not classified
Planning a device like Snowden-Pencer’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report