Cleared Traditional

SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP

K940371 · Micromedics, Inc. · General Hospital
Apr 1994
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K940371 is an FDA 510(k) clearance for the SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP, a Syringe, Irrigating (non Dental) (Class I — General Controls, product code KYZ), submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on April 6, 1994, 90 days after receiving the submission on January 6, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K940371 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1994
Decision Date April 06, 1994
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KYZ — Syringe, Irrigating (non Dental)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6960