Cleared Traditional

K844074 - HOBBS MEDICAL POLYPECTOMY SNARE

K844074 is the FDA 510(k) clearance for HOBBS MEDICAL POLYPECTOMY SNARE by Hobbs Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCZ) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K844074 · Hobbs Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
76d
Days
Class 2
Risk

K844074 is an FDA 510(k) clearance for the HOBBS MEDICAL POLYPECTOMY SNARE. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Hobbs Medical, Inc. (Palmer, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 76 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 K844074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1984
Decision Date January 03, 1985
Days to Decision 76 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
54d faster than avg
Panel avg: 130d · This submission: 76d
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 K844074.
(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