FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OverStitch NXT Endoscopic Suturing System
K Number: K231553
·
Decision Jun 29, 2023
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
12
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OverStitch NXT Endoscopic Suturing System
- K Number
- K231553
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apollo Endosurgery, Inc.
- Date Received
- May 30, 2023
- Decision Date
- June 29, 2023
- Product Code
- OCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCW), ordered by most recent decision date.
Endomina EZFuse system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SimpleStitch Suturing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MaxTack Motorized Fixation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MedicloseTM System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
endomina system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Su2ura Approximation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Apollo Endosurgery, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Sep 18, 2023 | Substantially Equivalent |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | Jul 12, 2022 | Unknown |
| K210266 | OverStitch Sx Endoscopic Suturing System | Mar 2, 2021 | Substantially Equivalent |
| K201808 | X-Tack Endoscopic HeliX Tacking System | Dec 15, 2020 | Substantially Equivalent |
| K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Nov 15, 2017 | Substantially Equivalent |
| K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM | Sep 28, 2012 | Substantially Equivalent |
| K103155 | SUMO ACCESS AND TISSUE RESECTION SYSTEM | Oct 28, 2011 | Substantially Equivalent |
| K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 | Jun 14, 2010 | Unknown |
| K090583 | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 | Jun 26, 2009 | Substantially Equivalent |
| K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 | Dec 19, 2008 | Substantially Equivalent |