FDA applicant
KARL STORZ Endoscopy-America, Inc.
FDA records 370 decisions for KARL STORZ Endoscopy-America, Inc. (Culver City, CA) from 1980 to 2026: 367 510(k) clearances and 3 original PMA approvals. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HET (Laparoscope, Gynecologic (And Accessories)). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 127 predicates, 65 of them its own earlier devices. 43 recalls are linked to its devices.
FDA’s records also spell it “Karl Storz Endoscopy America, Inc.”, “Karl Storz Endoscopy America”, “Karl Storz-Endoscopy-America, Inc.”, “Karl Storz Endoscopy_America, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided KARL STORZ Endoscopy-America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like KARL STORZ Endoscopy-America, Inc.’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 “KARL”
FDA records each applicant name separately; these may or may not be the same firm.