510(k) · Cleared

Recalled · Class II · 2013

Ultraclip Tissue Marker

K993785510(k) TraditionalCleared Feb 4, 200088-day reviewClass II21 CFR 878.4750Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Inrad · GDW Staple, Implantable

Cleared on Feb 4, 2000 as substantially equivalent to K970817 (Biopsys Medical, Inc., 1997) after an 88-day review. Its family tree reaches back 1 generation to 1997. 28 later devices descend from it. It has been recalled once.

Decided: Feb 4, 2000
Review: 88 days
Class: Class II
Product code: GDW
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K970817 (1997). 28 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK970817 Micromark ClipBiopsys Medical, Inc. · 1997
This deviceK993785 Ultraclip Tissue MarkerInrad · 2000
Descendant · cites it directly · 25 of its ownK033447 Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM…Mri Devices Corp. · 2004
Descendant · 2 generations on · 23 of its ownK073095 Tumark Professional, Model 271560; MR- Tumark Professional, Model…Somatex Medical Technologies GmbH · 2008 · Recalled
Descendant · 2 generations on · 21 of its ownK093064 Tumark Professional, Model 271560, MR-Tumark Professional, Model…Somatex Medical Technologies GmbH · 2010
Descendant · 3 generations on · 16 of its ownK111692 Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011
Descendant · 4 generations on · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2004high 4 (2018) · low 0 (2005)2026

Most influential descendants

Showing 5 of 28 · See all

K033447Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…Mri Devices Corp. · 2004 · cites it directly25descendants
K073095Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2008 · 2 generations on23descendants
K093064Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560Somatex Medical Technologies GmbH · 2010 · 2 generations on21descendants
K111692Tumark Flex for Mammotome,Tumark Flex for AtecSomatex Medical Technologies GmbH · 2011 · 3 generations on16descendants
K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · 4 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970817	Micromark Clip	Biopsys Medical, Inc.	1997	—
0 (this device)	K993785	Ultraclip Tissue Marker	Inrad	2000	—
+1	K033447	Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models…	Mri Devices Corp.	2004	—
+2	K073095	Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560	Somatex Medical Technologies GmbH	2008	1
+2	K093064	Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560	Somatex Medical Technologies GmbH	2010	—
+3	K111692	Tumark Flex for Mammotome,Tumark Flex for Atec	Somatex Medical Technologies GmbH	2011	—
+4	K120804	Cianna Medical Tissue Marker and Delivery System	Cianna Medical	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2008	1	0
2010	1	0
2011	1	0
2012	1	0
2013	2	0
2016	1	0
2017	1	0
2018	4	0
2019	1	0
2021	3	0
2022	1	0
2023	4	0
2024	4	0
2025	1	0

FIG. 1 — Lineage of K993785, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GDW device

#1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K970817	Micromark Clip Summary page 1 …E: Proprietary Name: UltraClip Tissue Marker Common/Usual Name: UltraClip Tissue Marker Classification Name: Staple, Implantable 3. PREDICATE DEVICE: Micromark Clip (K970817) Biopsys Medical, Inc. 3 Morgan Irving, CA 92718 4. DESCRIPTION OF THE DEVICE: A sterile, single patient use device comprised…	Biopsys Medical, Inc.	1997	—

Also cleared against K970817: 3 other devices →

What descends from it? (28)

See all 28

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033447	Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…	Mri Devices Corp.	2004	25
K183503	EasyMark Tissue Marker	Inrad, Inc.	2019	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 16, 2013	Class II	Z-1524-2013	Nonconforming Material/Component	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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K033447 (Mri Devices Corp., 2004) has gone furthest, with 25 descendants of its own.
3 other devices also cite its predicate K970817.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDW

3in 2025

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GDW

3in 2025

2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	56	9	2,401
2008	7	57	0	2,380
2009	13	27	22	4,014
2010	10	39	2	3,768
2011	11	49	9	3,826
2012	9	45	11 (1)	3,717
2013	13	49	1	3,777
2014	15	63	0	4,784
2015	8	111	6	4,899
2016	11	96	2	5,106
2017	13	103	3	11,643
2018	7	90	3	14,914
2019	12	205	4 (4)	16,600
2020	10	88	11	12,332
2021	9	233	0	13,015
2022	7	89	0	13,605
2023	4	267	1	14,623
2024	2	—	0	13,280
2025	3	111	3	11,905
2026	3	141	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993785 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993785: Ultraclip Tissue Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993785

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026