FDA applicant
Apollo Endosurgery, Inc.
FDA records 14 decisions for Apollo Endosurgery, Inc. (Austin, TX) from 2008 to 2023: 13 510(k) clearances and 1 De Novo grant. Most are in product codes OCW (Endoscopic Tissue Approximation Device) and FED (Endoscopic Access Overtube…). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 164 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Apollo Endosurgery”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Apollo Endosurgery, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Apollo Endosurgery, 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 “Apollo”
FDA records each applicant name separately; these may or may not be the same firm.