Cleared Traditional

K833125 - HOBBS MEDICAL GRASPING FORCEPS

K833125 is the FDA 510(k) clearance for HOBBS MEDICAL GRASPING FORCEPS by Hobbs Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCZ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K833125 · Hobbs Medical, Inc. · Gastroenterology & Urology device
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Oct 1983
Decision
48d
Days
Class 2
Risk

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

Submitted by Hobbs Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hobbs Medical, Inc. devices

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCZ Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCZ Endoscopic Grasping/cutting Instrument, Non-powered

All 37
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K833125.
(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE
K870355 · Cook Urological, Inc. · Apr 1987
VAN-TEC DOUBLE SHEATH GRASPING FORCEPS
K865087 · Van-Tec, Inc. · Mar 1987
DAVOL RETRIEVAL BASKETS & FORCEPS
K845017 · C.R. Bard, Inc. · Jan 1985
LOOP RETRIEVER
K830802 · Van-Tec, Inc. · Apr 1983
RETRIEVABLE FORCEPS
K792345 · Mill-Rose Laboratory · Dec 1979
FORCEPS, GRASPING
K760180 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976