ENDONEEDLE— 510(k) K844619

Substantially Equivalent

Endotherapeutics

FDA 510(k) clearance K844619 for ENDONEEDLE, Substantially Equivalent on 1985-01-09. Applicant: Endotherapeutics. Device class: 2.

Clearance details

Applicant: Endotherapeutics
Product code: Code FHO
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1984-11-27
Decision date: 1985-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHO

K172120 — Veress Needle2017-09-14
K121370 — VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE2013-08-02
K010779 — MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT2001-04-10
K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE1997-03-27
K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM1996-08-05

More clearances from Endotherapeutics

K870855 — UROSCAN1987-06-09
K860192 — ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE1986-03-17
K860102 — MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE1986-02-12
K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE1986-02-12
K852031 — ENDOPORT 5MM1985-08-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.