Modification to Implantable Clip
FDA 510(k) K011236 · Applied Medical Resources Corp.
510(k) numberK011236
Submission
- Device name
- Modification to Implantable Clip
- Applicant
- Applied Medical Resources Corp.
Rancho Santa, CA, US - Received
- April 23, 2001
- Decision date
- May 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZP – Clip, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | Teleflex Medical | 01/12/2024SE |
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Questions and answers
When was Modification to Implantable Clip cleared by the FDA?
Modification to Implantable Clip (K011236) received a 510(k) decision of Substantially Equivalent on May 14, 2001, 21 days after the submission was received.
What is the product code of K011236?
The FDA product code is FZP – Clip, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.