FDA applicant
New England Surgical Instrument Corp.
FDA records 18 decisions for New England Surgical Instrument Corp. (Rockland, MA) from 1981 to 1989: 18 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FFA (Tube, Drainage, Suprapubic). 8 recalls are linked to its devices, 7 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided New England Surgical Instrument Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for New England Surgical Instrument Corp. since 2007.
Recalls per year
7in 2024
Class I Class II/III not classified
Planning a device like New England Surgical Instrument Corp.’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