Neotract Anchor
FDA 510(k) K061700 · Neotract, Inc.
510(k) numberK061700
Submission
- Device name
- Neotract Anchor
- Applicant
- Neotract, Inc.
Pleasanton, CA, US - Received
- June 16, 2006
- Decision date
- October 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
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| K200441 | UroLift Advanced Tissue Control (ATC) SystemPEW · Traditional | 06/05/2020SE |
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| K193269 | UroLift System (UL400)PEW · Special | 12/20/2019SE |
| K190377 | UroLift System UL400PEW · Special | 03/21/2019SE |
| K173087 | UroLift System (UL400 and UL500)PEW · Traditional | 12/28/2017SE |
| K172359 | UroLift System (UL500)PEW · Special | 08/18/2017SE |
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Questions and answers
When was Neotract Anchor cleared by the FDA?
Neotract Anchor (K061700) received a 510(k) decision of Substantially Equivalent on October 26, 2006, 132 days after the submission was received.
What is the product code of K061700?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.