# Apollo Endosurgery, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 14 (2008–2023): 13 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Apollo Endosurgery, Inc. (12); Apollo Endosurgery (2)
- Product codes: OCW (6), FED (2), QTD (2), KGE (1), KNS (1), ODC (1), PKL (1)
- 510(k) review time since 2016: median 30 days, against 164 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 21 (7 its own); citations of its devices by later devices: 13 (7 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cordis Corp.: 2 (https://510kreport.com/company/cordis)
- Ethicon Endo-Surgery, Inc.: 2 (https://510kreport.com/company/ethicon-endo-surgery)
- United States Surgical, A Division of Tyco Healthc: 2 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Medi-Globe Corp.: 2 (https://510kreport.com/company/medi-globe)
- Telemed Systems, Inc.: 1 (https://510kreport.com/company/telemed-systems)
- Surgical Innovations Plc: 1 (https://510kreport.com/company/surgical-innovations)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Cook Ireland, Ltd.: 1 (https://510kreport.com/company/cook-ireland)

## Firms that cite its devices most
- Slater Endoscopy, LLC: 2 (https://510kreport.com/company/slater-endoscopy)
- Xlumena, Inc.: 1 (https://510kreport.com/company/xlumena)
- Envision Endoscopy: 1 (https://510kreport.com/company/envision-endoscopy)
- Endo Tools Therapeutics S.A.: 1 (https://510kreport.com/company/endo-tools-therapeutics)
- Softac Medical Technologies: 1 (https://510kreport.com/company/softac-medical-technologies)

## Its most-cited devices
- K171886: OverStitch SX Endoscopic Suturing System (ESS) (2017), cited by 3
- K090583: Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 (2009), cited by 2
- K082114: Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 (2008), cited by 2
- K181141: OverStitch Endoscopic Suturing System and Accessories (2018), cited by 2
- K081853: Overstitch Endoscopic Suture System (2008), cited by 1
- K210266: OverStitch Sx Endoscopic Suturing System (2021), cited by 1

## Recent decisions
- K232544: Apollo ESG NXT System, Apollo REVISE NXT System (Sep 18, 2023)
- K231553: OverStitch NXT Endoscopic Suturing System (Jun 29, 2023)
- DEN210045: APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System (Jul 12, 2022)
- K210266: OverStitch Sx Endoscopic Suturing System (Mar 2, 2021)
- K201808: X-Tack Endoscopic HeliX Tacking System (Dec 15, 2020)
- K191439: OverStitch 2-0 Polypropylene Suture (Aug 29, 2019)
- K181141: OverStitch Endoscopic Suturing System and Accessories (Jun 27, 2018)
- K171886: OverStitch SX Endoscopic Suturing System (ESS) (Nov 15, 2017)

Source page: https://510kreport.com/company/apollo-endosurgery