HABIB ENDOHPB— 510(k) K083292

Clearance details

Applicant

Emcision , Ltd.

Product code

Code KNS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2008-11-10

Decision date

2009-06-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

London, Uk, GB

• K262460 — Rezum System2026-09-03
• K260962 — Sphincterotome2026-05-21
• K252388 — Vanquish Water Vapor Ablation Device2025-11-26
• K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)2025-11-25
• K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more2025-10-17

• K180165 — Habib EndoHPB2018-03-20
• K161305 — Habib EUS RFA2016-07-07
• K150029 — Habib EUS RFA2015-06-24
• K080717 — HABIB HEXABLATE 102008-03-27
• K073687 — HABIB LAPAROSCOPIC HEXABLATE2008-01-09

Death

44

Injury

2,361

Malfunction

4,771

Total

7,176

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1397-2023 — Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070Class II·Ongoing·Boston Scientific Corporation·20230202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083292.