FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
K Number: K090583
·
Decision Jun 26, 2009
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
45
Applicant Total
12
Review Days
114
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Basic Information
- Device Name
- ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
- K Number
- K090583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apollo Endosurgery, Inc.
- Date Received
- March 4, 2009
- Decision Date
- June 26, 2009
- Product Code
- KGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KGE | Forceps, Biopsy, Electric | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Apollo Endosurgery, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Sep 18, 2023 | Substantially Equivalent |
| K231553 | OverStitch NXT Endoscopic Suturing System | Jun 29, 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 |
| K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 | Dec 19, 2008 | Substantially Equivalent |