Cleared Traditional

K001630 - KSEA BIPOLAR COAGULATING ELECTRODES

K001630 is an FDA 510(k) clearance for KSEA BIPOLAR COAGULATING ELECTRODES, manufactured by Karl Storz Endoscopy. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K001630 · Karl Storz Endoscopy · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
54d
Days
Class 2
Risk

K001630 is an FDA 510(k) clearance for the KSEA BIPOLAR COAGULATING ELECTRODES. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on July 19, 2000 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - the FDA neurology 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 Karl Storz Endoscopy devices

FDA 510(k) Submission Details - K001630

510(k) Number K001630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2000
Decision Date July 19, 2000
Days to Decision 54 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 148d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWG Device Classification - Class 2, Special Controls

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Neurology devices follow this clearance model.

Regulatory Peers - GWG Endoscope, Neurological

All 87
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K001630.
KSEA MINIATURE NEUROENDOSCOPE
K002704 · KARL STORZ Endoscopy-America, Inc. · Nov 2000
KSEA NEURO-FIBERSCOPE
K002788 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
NAVIGUS PEEL AWAY INTRODUCER
K002330 · Image-Guided Neurologics, Inc. · Oct 2000
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
K993568 · Machida Endoscope Co., Ltd. · Mar 2000
DCI ENDOSCOPE
K993539 · KARL STORZ Endoscopy-America, Inc. · Dec 1999
MITAKA POINT SETTER
K991989 · Mitaka USA, Inc. · Aug 1999