Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Apollo Endosurgery, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
367 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. | 2023-09-18 | 27 | 0 |
| K231553 | OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2023-06-29 | 30 | 0 |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE Syste | Apollo Endosurgery, Inc. | 2022-07-12 | 285 | 0 |
| K210266 | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | 2021-03-02 | 29 | 0 |
| K201808 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2020-12-15 | 167 | 2 |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017-11-15 | 142 | 0 |
| K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM | Apollo Endosurgery, Inc. | 2012-09-28 | 60 | 0 |
| K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM | Apollo Endosurgery, Inc. | 2011-10-28 | 367 | 0 |
| K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 | Apollo Endosurgery, Inc. | 2010-06-14 | 689 | 0 |
| K090583 | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 | Apollo Endosurgery, Inc. | 2009-06-26 | 114 | 0 |
| K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-00 | Apollo Endosurgery, Inc. | 2008-12-19 | 144 | 0 |
| K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM | Apollo Endosurgery, Inc. | 2008-08-18 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda