# K013759: MSS-28CS-301/701 Needlescope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Aug 20, 2002 after 280 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923555 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971340: Olympus Neuro Endoscope, Olympus Optical, Co. (1998). Our reading of the summary gave K973140, FDA’s number for Duet Glucose Control Monitoring System (Lxn Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Olympus Neuro Endoscope A7595”.

## Cited in the summary but kept off the family tree
- K993568: Machida Flexible Neuro-Endoscope, Models Neu-4, Neu-4L, Machida Endoscope Co., Ltd. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
OLYMPUS NEEDLESCOPE MSS-Z8CS-301/701 has been designed-to be combined with the OPERATION MICROSCOPE OME-8000 for use in observation of the brain ventrides/ , and the brain parenchyma, in confirmation of clips on cerebral aneurysms, and for performing diagnostic procedures, such as observation of cerebrat aneurysms, observatiorr of cerebral tissues including brairr tumors, observation of cerebral vascular systems and cranial nerves, and observation-of hypophysis tumors.

Source page: https://510kreport.com/device/K013759
Methodology: https://510kreport.com/methodology