# K962255: Clarus Murphypen Endoscope (2127-XXX)

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical Systems, Inc.
- Decided: Sep 11, 1996 after 91 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912089 (1991). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912089: Modified Series 2100 Endoscopes, Medical Laser, Inc. (1991) Summary page 2.
- K934432: Otoview Endoscopy System, Smith & Nephew Richards, Inc. (1994) Summary page 2.
- (no number) Model 2126 SpinePEN Endoscope: named in the summary without a submission number
- (no number) Model 2120 NeuroPEN Endoscope: named in the summary without a submission number
- (no number) Model 2125 MurphyScope: named in the summary without a submission number
- (no number) Model 2400 InstrumentScope: named in the summary without a submission number
- (no number) Model 2240 Otoscope: named in the summary without a submission number
- (no number) Model Number C-DFO-1.6-40-Radiscope™ Optical Fiber: named in the summary without a submission number
- (no number) Model S1002 Diaguide: named in the summary without a submission number
- (no number) Model SLS Endoscope: named in the summary without a submission number

## Most influential descendants
- K991377: Omnisonics Flexible Fiber Optic Endoscope and Coupler (1999), 2 descendants of its own
- K082038: Clarus Video Airway Endoscope, Models 30000-V and 30003-V (2009), 0 descendants of its own
- K080780: Anchorage Scope, Model 000003 (2008), 0 descendants of its own
- K993445: Omnisonic Endoscopic Deflector (1999), 0 descendants of its own

## Indications for use
The Clarus Model 2126 SpinePEN is intended for diagnostic accessing and visualizing tissue during cranial sinus, laryngopharyngeal and bronchial procedures. It is not intended for intraoperative or percutaneous use. The endoscope is reusable and is packaged with five disposable cannulae.

Source page: https://510kreport.com/device/K962255
Methodology: https://510kreport.com/methodology