FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VESSEL LOOPS
K Number: K895682
·
Decision Oct 24, 1989
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
25
Applicant Total
23
Review Days
33
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Basic Information
- Device Name
- VESSEL LOOPS
- K Number
- K895682
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Applied Medical Technologies
- Date Received
- September 21, 1989
- Decision Date
- October 24, 1989
- Product Code
- GDX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GDX | Scalpel, One-Piece | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Applied Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K971434 | A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE | Aug 17, 1998 | Substantially Equivalent |
| K972478 | PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES | Feb 9, 1998 | Substantially Equivalent |
| K973893 | AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE | Dec 19, 1997 | Substantially Equivalent |
| K971757 | LOW PROFILE FEEDING SET ACCESSORY | Nov 7, 1997 | Substantially Equivalent |
| K971758 | CAUTERIZATION SMOKE EVACUATOR | Jul 21, 1997 | Substantially Equivalent |
| K961345 | DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE | Sep 17, 1996 | Substantially Equivalent |
| K960232 | ENDOSCOPIC ACCESS DEVICE | Mar 21, 1996 | Substantially Equivalent |
| K945618 | GASTROINTESTINAL TUBES & ACCESSORIES | Oct 12, 1995 | Substantially Equivalent |
| K946140 | PRG BUTTON | Aug 28, 1995 | Substantially Equivalent |
| K923488 | GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY | Jul 20, 1995 | Substantially Equivalent |