FDA applicant
Stryker Endoscopy
FDA records 103 decisions for Stryker Endoscopy (San Jose, CA) from 1993 to 2026: 102 510(k) clearances and 1 De Novo grant. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HRX (Arthroscope). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 125 predicates, 40 of them its own earlier devices. 75 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stryker Endoscopy’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
6in 2026
Class I Class II/III not classified
Planning a device like Stryker Endoscopy’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 “Stryker”
FDA records each applicant name separately; these may or may not be the same firm.