Company ยท US
Apollo Endosurgery, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2023. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | 6 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 |
| LTI | Implant, Intragastric For Morbid Obesity | 2 |
| QTD | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss | 2 |
| KGE | Forceps, Biopsy, Electric | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| ODC | Endoscope Channel Accessory | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2023 | K232544 | Apollo ESG NXT System, Apollo REVISE NXT System Apollo Endosurgery, Inc. | QTD |
| Jun 29, 2023 | K231553 | OverStitch NXT Endoscopic Suturing System Apollo Endosurgery, Inc. | OCW |
| Jul 12, 2022 | DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System Apollo Endosurgery, Inc. | QTD |
| Mar 2, 2021 | K210266 | OverStitch Sx Endoscopic Suturing System Apollo Endosurgery, Inc. | OCW |
| Dec 15, 2020 | K201808 | X-Tack Endoscopic HeliX Tacking System Apollo Endosurgery, Inc. | PKL |
| Aug 29, 2019 | K191439 | OverStitch 2-0 Polypropylene Suture Apollo Endosurgery | OCW |
| Jun 27, 2018 | K181141 | OverStitch Endoscopic Suturing System and Accessories Apollo Endosurgery | OCW |
| Nov 15, 2017 | K171886 | OverStitch SX Endoscopic Suturing System (ESS) Apollo Endosurgery, Inc. | OCW |
| Sep 28, 2012 | K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM Apollo Endosurgery, Inc. | FED |
| Oct 28, 2011 | K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM Apollo Endosurgery, Inc. | ODC |
| Jun 14, 2010 | K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 Apollo Endosurgery, Inc. | FED |
| Jun 26, 2009 | K090583 | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 Apollo Endosurgery, Inc. | KGE |
| Dec 19, 2008 | K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 Apollo Endosurgery, Inc. | KNS |
| Aug 18, 2008 | K081853 | OVERSTITCH ENDOSCOPIC SUTURE SYSTEM Apollo Endosurgery, Inc. | OCW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2017 | Apollo Endosurgery Inc Apollo Lap-Band AP System Small with RapidPort EZ
Product Usage:
The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the band Terminated |
LTI | None listed |
| Sep 30, 2014 | Apollo Endosurgery Inc LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes.
The LAP-BAND System is indicated for we Terminated |
LTI | None listed |