Cleared Traditional

K833125 - HOBBS MEDICAL GRASPING FORCEPS

K833125 is an FDA 510(k) clearance for HOBBS MEDICAL GRASPING FORCEPS, manufactured by Hobbs Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K833125

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 131d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCZ Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K833125.
DAVOL RETRIEVAL BASKETS & FORCEPS
K845017 · C.R. Bard, Inc. · Jan 1985
HOBBS MEDICAL POLYPECTOMY SNARE
K844074 · Hobbs Medical, Inc. · Jan 1985
HOBBS MEDICAL RETRIEVAL BASKET
K833124 · Hobbs Medical, Inc. · Nov 1983
LOOP RETRIEVER
K830802 · Van-Tec, Inc. · Apr 1983
SPIRAL STONE AND RETRIEVAL BASKETS
K820429 · American Endoscopy, Inc. · Apr 1982
RETRIEVABLE FORCEPS
K792345 · Mill-Rose Laboratory · Dec 1979