# K014149: Paediscope, Model # P010A and PF011A

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Mar 18, 2002 after 90 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: 1 generation back to K954899 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983365: Aesculap Minop System, Aesculap, Inc. (1998) Summary page 2.
- K954394: Aesculap Ventriculoscope System, Aesculap, Inc. (1996) Summary page 2.
- K954899: Rigid Neuroview Endoscope, Neuro Navigational Corp. (1995) Summary page 2.
- K002572: Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005, Medtronic PS Medical (2000) Summary page 2.
- K002704: Ksea Miniature Neuroendoscope, KARL STORZ Endoscopy-America, Inc. (2000) Summary page 2.

## Indications for use
Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for direct visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

Source page: https://510kreport.com/device/K014149
Methodology: https://510kreport.com/methodology