# K993785: Ultraclip Tissue Marker

- Pathway: 510(k) (Traditional)
- Applicant: Inrad
- Decided: Feb 4, 2000 after 88 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970817 (1997). 1 ancestor in all.
28 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970817: Micromark Clip, Biopsys Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K033447: Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370, 12372, 12376 (2004), 25 descendants of its own
- K073095: Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560 (2008), 23 descendants of its own
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 (2010), 21 descendants of its own
- K111692: Tumark Flex for Mammotome,Tumark Flex for Atec (2011), 16 descendants of its own
- K120804: Cianna Medical Tissue Marker and Delivery System (2013), 15 descendants of its own

## Recalls of this device
- Apr 16, 2013 · Class II · Z-1524-2013: Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.

## Indications for use
The UltraClip Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

Source page: https://510kreport.com/device/K993785
Methodology: https://510kreport.com/methodology