← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

PJK — Tissue Adhesive For Internal Use

Approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.

DEVICE CLASS
Class III
REGULATION
21 CFR 878.4010
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →