FDA applicant
Performance Surgical Instruments Corp.
FDA records 2 decisions for Performance Surgical Instruments Corp. (Holbrook, MA) from 1991 to 1994: 2 510(k) clearances. All are in product code GCJ (Laparoscope, General & Plastic Surgery). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Performance Surgical Instruments Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Performance Surgical Instruments Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Performance Surgical Instruments 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) ReportOther applicant names beginning “Performance”
FDA records each applicant name separately; these may or may not be the same firm.