Reprocessed Multiple Clip Appliers
FDA 510(k) K033579 · Clearmedical, Inc.
510(k) numberK033579
Submission
- Device name
- Reprocessed Multiple Clip Appliers
- Applicant
- Clearmedical, Inc.
Bellevue, WA, US - Received
- November 13, 2003
- Decision date
- July 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NMJ – Clip, Implantable, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
More from Clearmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033578 | Reprocessed Reloadable Cutters, Staplers, and AppliersNLL · Traditional | 07/11/2005SE |
| K033591 | Reprocessed TrocarsKBG · Traditional | 06/03/2005SE |
| K033592 | Reprocessed Surgical Scissors and GraspersGEI · Traditional | 07/27/2004SE |
| K033593 | Reprocessed Single Use Devices Biopsy ForcepsNLU · Traditional | 11/20/2003SE |
| K031416 | Clearmedical/Critikon Blood Pressure Cuff; Clearmedical/Welch Allyn Blood Pressure CuffDXQ · Traditional | 07/15/2003SE |
| K012622 | Clearmedical/Nellcor Oxisensor II, Pediatric, Model D-20NLF · Traditional | 07/03/2002SE |
| K012609 | Clearmedical/Nellcor Oxisensor II, Neonatal/Adult, Model N-25NLF · Traditional | 07/03/2002SE |
| K012600 | Clearmedical/Nellcor Oxisensor II, Adult, Model D-25/D-25LNLF · Traditional | 07/03/2002SE |
| K012621 | Clearmedical/Hentleigh Deep Vein Thrombosis (DVT) GarmentJOW · Traditional | 02/06/2002SE |
| K012616 | Clearmedical/Huntleigh Foot Garments; Models FG200/LRG (Large), FG200/STD (Standard)…JOW · Traditional | 02/06/2002SE |
Questions and answers
When was Reprocessed Multiple Clip Appliers cleared by the FDA?
Reprocessed Multiple Clip Appliers (K033579) received a 510(k) decision of Substantially Equivalent on July 11, 2005, 606 days after the submission was received.
What is the product code of K033579?
The FDA product code is NMJ – Clip, Implantable, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 878.4300.