FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
AMT T-FASTENER ANCHOR KIT
K Number: K120587
·
Decision May 25, 2012
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
25
Review Days
88
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Basic Information
- Device Name
- AMT T-FASTENER ANCHOR KIT
- K Number
- K120587
- 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
- February 27, 2012
- Decision Date
- May 25, 2012
- Product Code
- KGC
- 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 |
|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | 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 |