# K983538: Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing Capability

- Pathway: 510(k) (Special)
- Applicant: Solos Endoscopy, Inc.
- Decided: Nov 6, 1998 after 28 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K926166 (1993). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932987: Birtcher Laparoscope and Accessories, Birtcher Medical Systems, Inc. (1994) Summary page 1.
- K926166: Coast Video Endoscopic Imaging System, Optik (1993) Summary page 1.
- K971996: Medivision Arthroscop, Medivision Scope Service Center, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K931065: Laparoview, Northgate Technologies, Inc. (1994). Our OCR of the scanned summary read K931065, FDA’s number for Laparoview (Northgate Technologies, Inc.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 1.

## Most influential descendants
- K983527: Microendoscope, Miniaturized Biopsy Scope (1999), 4 descendants of its own
- K051073: Midiview Series of Microendoscopes (2006), 2 descendants of its own
- K093785: Modular Endoscope (2010), 0 descendants of its own
- K082735: Stone Grasping Basket, Model PD-T1 2115 (2009), 0 descendants of its own
- K040949: Viaduct Miniscope and Accessories (2004), 0 descendants of its own

## Indications for use
The Indications for this device use is when medical practitioner needs visualization in order to view surgical procedures, gaining access either through a natural orifice or incision.

Source page: https://510kreport.com/device/K983538
Methodology: https://510kreport.com/methodology