Cleared Traditional

K833125 - HOBBS MEDICAL GRASPING FORCEPS (FDA 510(k) Clearance)

Oct 1983
Decision
48d
Days
Class 2
Risk

K833125 is an FDA 510(k) clearance for the HOBBS MEDICAL GRASPING FORCEPS. This device is classified as a Endoscopic Grasping/cutting Instrument, Non-powered (Class II - Special Controls, product code OCZ).

Submitted by Hobbs Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983, 48 days after receiving the submission on September 13, 1983.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope..

Submission Details

510(k) Number K833125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1983
Decision Date October 31, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code OCZ — Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.