Cleared Traditional

K874008 - OVAL CUP HOT BIOPSY FORCEP (MODEL B-51)

K874008 is the FDA 510(k) clearance for OVAL CUP HOT BIOPSY FORCEP (MODEL B-51) by Endovations. It is a Class 2 Gastroenterology & Urology device (product code OCZ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K874008 · Endovations · Gastroenterology & Urology device
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Dec 1987
Decision
89d
Days
Class 2
Risk

K874008 is an FDA 510(k) clearance for the OVAL CUP HOT BIOPSY FORCEP (MODEL B-51). Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Endovations (Camp Hill, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 89 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 Endovations devices

Submission Details

510(k) Number K874008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1987
Decision Date December 29, 1987
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
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 36
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K874008.
RAT TOOTH GRASPING FORCEP (MODEL 23/20)
K874005 · Endovations · Dec 1987
GRASPING TRIPOD FORCEP (MODEL 23/25)
K874006 · Endovations · Dec 1987
OVAL CUP HOT BIOPSY FORCEP (MODEL A-51)
K874007 · Endovations · Dec 1987
OVAL CUP HOT BIOPSY FORCEP (MODEL C-52)
K874009 · Endovations · Dec 1987
ROUND CUP HOT BIOPSY FORCEP (MODEL D-52)
K874010 · Endovations · Dec 1987
OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)
K874011 · Endovations · Dec 1987