Trocar, Reprocessed
The trocar (reprocessed) is a surgical instrument used to create ports of access into body cavities, commonly used in minimally invasive procedures. It is classified as FDA Class 2 under regulation 870.1390 in the Cardiovascular specialty, requiring 510(k) premarket notification. As a reprocessed single-use device, reprocessing validation data must be included in the 510(k) submission per the reprocessing guidance (70 FR 56911). Product code NMK is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- NMK
- Device Class
- FDA class 2
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K192998 | Reprocessed BRK Transseptal Needle | Jul 22, 2020 | Substantially Equivalent | Innovative Health, LLC |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.