MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE

Needle, Pneumoperitoneum, Simple

ENDOTHERAPEUTICS

The following data is part of a premarket notification filed by Endotherapeutics with the FDA for Mod. Endoneedle Single-use Pneumoperitoneum Needle.

Pre-market Notification Details

Device IDK860102
510k NumberK860102
Device Name:MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
ClassificationNeedle, Pneumoperitoneum, Simple
Applicant ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City,  CA  94063
ContactRussell Thompson
CorrespondentRussell Thompson
ENDOTHERAPEUTICS 654 BAIR ISLAND RD. SUITE 209 Redwood City,  CA  94063
Product CodeFHP  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-10
Decision Date1986-02-12

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