Staple, Implantable, Reprocessed
The Reprocessed Implantable Staple is a reprocessed surgical staple used for tissue approximation and wound closure in surgical procedures; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLL and regulation 21 CFR 878.4750 in the General and Plastic Surgery specialty. The device is not flagged as an implant in this classification record and is not life-sustaining.
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Basic Information
- Product Code
- NLL
- Device Class
- FDA class 2
- Regulation Number
- 878.4750
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070930 | REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS | Oct 18, 2007 | Substantially Equivalent | Sterilmed, Inc. |
| K070859 | REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS | Sep 12, 2007 | Substantially Equivalent | Sterilmed, Inc. |
| K033578 | REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS | Jul 11, 2005 | Substantially Equivalent | Clearmedical, Inc. |