BILE ENDOPROSTHESIS SET— 510(k) K860534

Clearance details

Applicant

Angiomed U.S., Inc.

Product code

Code GBZ

Device class

Class 1

Regulation

21 CFR 878.4200

Advisory panel

General, Plastic Surgery

Date received

1986-02-12

Decision date

1986-03-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Anaheim, CA, US

• K973621 — PRE-VIEW CHOLANGIOGRAPHY CLAMP1997-12-17
• K944790 — FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER1994-11-29
• K942450 — ENDOPATH1994-08-05
• K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER1993-08-10
• K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE1993-07-13

• K874771 — ANGIOMED INTRODUCING SETS1988-01-12
• K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE1987-12-02
• K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT1987-01-30
• K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS1986-10-24
• K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE1986-09-29

Death

2

Total

2

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 →