# K983527: Microendoscope, Miniaturized Biopsy Scope

- Pathway: 510(k) (Traditional)
- Applicant: Dofi Technologies, Inc.
- Decided: Jan 19, 1999 after 103 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: 2 generations back to K926166 (1993). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983538: Miniaturized Biopsy,Scope a.K.a: Biopsy Needle with Endoscopic Viewing Capability, Solos Endoscopy, Inc. (1998). Cleared while this submission was under review Summary page 1.
- K935834: Tas-211/2.3 Ultrathin Flexible Endoscope, Technology Marketing Group (1994) Summary page 1.
- K910732: Candela Mini-UB Endoscope, Candela Laser Corp. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K936857: Unnamed device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K911090: Omega Angioscopes (Omegascopes), Omega Universal Technologies, Ltd. (1991). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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 for medical practitioner needing visualization of soft tissue, either through a natural orifice or incision.

Source page: https://510kreport.com/device/K983527
Methodology: https://510kreport.com/methodology