FDA.report

510(k) K992218

Device
DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
Applicant
KIRWAN SURGICAL PRODUCTS, INC.
510(k) number
K992218
Product code
GEI  
Decision
Substantially Equivalent (SESE)
Decision date
1999-07-30
Date received
1999-07-01
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
KEVIN P PRARIO
Address
180 Enterprise Dr. Marshfield MA US 02050 02050

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
10841019121686KirwanKIRWAN SURGICAL PRODUCTS LLC2025-04-04
10841019122683Neuro-Tec / MD ResourcesKIRWAN SURGICAL PRODUCTS LLC2024-12-07

Legacy Summary

summary

FDA Review

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