Product code NMJ— General, Plastic Surgery

REPROCESSED MULTIPLE CLIP APPLIERS

Classification name: Clip, Implantable, Reprocessed
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Total cleared: 1
First cleared: 2005-07-11
Most recent: 2005-07-11

FDA classification definition

“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).”
— U.S. Food and Drug Administration, device classification record for product code NMJ under 21 CFR 878.4300, via openFDA

Market context for product code NMJ

FDA has cleared 1 device under product code NMJ, all in 2005, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NMJ

Clearmedical, Inc.1 clearance

Recent clearances under product code NMJ

K033579 — REPROCESSED MULTIPLE CLIP APPLIERSClearmedical, Inc.·2005-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.