Cleared Traditional

HAND-TROL S

K931215 · Aspen Labs · General & Plastic Surgery
Mar 1994
Decision
383d
Days
Class 2
Risk

About This 510(k) Submission

K931215 is an FDA 510(k) clearance for the HAND-TROL S, a Electrosurgical Device (Class II — Special Controls, product code DWG), submitted by Aspen Labs (Centennial, US). The FDA issued a Cleared decision on March 28, 1994, 383 days after receiving the submission on March 10, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K931215 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1993
Decision Date March 28, 1994
Days to Decision 383 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code DWG — Electrosurgical Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400