Alert detail
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
Policy ID: 2026-10621Specialty: Multi-specialtyAdded: 6/2/2026Effective: 2026-05-28federal rule
What changed
Final Rule published 2026-05-28. The Food and Drug Administration (FDA) is classifying the endoscopic suturing device for altering gastric anatomy for weight loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the endoscopic suturing device for altering gastric anatomy for weight loss. We are taking t
Who’s affected: Multi-specialty billing teams · Effective: 2026-05-28
Primary source: View the official CMS/MAC document ↗
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