FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
K Number: K073034
·
Decision Mar 14, 2008
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
25
Review Days
140
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Basic Information
- Device Name
- AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
- K Number
- K073034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Applied Medical Technology, Inc.
- Date Received
- October 26, 2007
- Decision Date
- March 14, 2008
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Applied Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252438 | Explant Express | Feb 3, 2026 | Substantially Equivalent |
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Nov 1, 2024 | Substantially Equivalent |
| K241111 | AMT Suture Passer | Jul 5, 2024 | Substantially Equivalent |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Dec 18, 2023 | Substantially Equivalent |
| K202539 | Nutriglide(TM) Nasal Feeding Tube | Oct 29, 2020 | Substantially Equivalent |
| K193612 | AMT Suture Delivery System | Mar 12, 2020 | Substantially Equivalent |
| K183508 | Micro Transgastric-Jejunal Feeding Device | Mar 29, 2019 | Unknown |
| K182804 | Traditional Length GJ Feeding Device | Mar 1, 2019 | Substantially Equivalent |
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | Jun 1, 2018 | Unknown |
| K170319 | Low Profile Non-Balloon Feeding Device | Oct 6, 2017 | Substantially Equivalent |