FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100

K Number: K002257 · Decision Oct 19, 2000
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
2
Review Days
86

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100
K Number
K002257
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Tecno Instruments (Pvt.) , Ltd.
Date Received
July 25, 2000
Decision Date
October 19, 2000
Product Code
GEI
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.

View all

Other Clearances by Tecno Instruments (Pvt.) , Ltd.

K Number Device Name
K042608 TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110