Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

NUJ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4400

Classification

FDA Product Code: NUJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4400
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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).

Market data

Cleared 510(k) submissions: 37
Registered establishments: 25

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown