510(k) · Cleared

Cleared

Auto Suture* Abbi* System

K963825510(k) TraditionalCleared Dec 20, 199687-day reviewClass II21 CFR 876.1075

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

United States Surgical, A Division of Tyco Healthc · KNW Instrument, Biopsy

Cleared on Dec 20, 1996 as substantially equivalent to K871390 (C.R. Bard, Inc., 1987) after an 87-day review. Its family tree reaches back 1 generation to 1987. 6 later devices descend from it.

Decided: Dec 20, 1996
Review: 87 days
Class: Class II
Product code: KNW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K871390 (1987). 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
This deviceK963825 Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc · 1996
Descendant · cites it directly · 5 of its ownK983296 Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc · 1999
Descendant · 2 generations on · 1 of its ownK020031 EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002…Neothermia Corp. · 2002
Descendant · 2 generations on · 1 of its ownK011575 22MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001
Descendant · 3 generations on · 0 of its ownK052246 Modification to EN-Bloc Biopsy SystemNeothermia Corporation · 2005
Descendant · 2 generations on · 0 of its ownK040087 RabbitScion International, Inc. · 2004

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1999high 2 (2002) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all

K983296Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc · 1999 · cites it directly5descendants
K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302Neothermia Corp. · 2002 · 2 generations on1descendant
K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001 · 2 generations on1descendant
K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation · 2005 · 3 generations on0descendants
K040087RabbitScion International, Inc. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871390	Bard Biopty Biopsy System	C.R. Bard, Inc.	1987	—
0 (this device)	K963825	Auto Suture* Abbi* System	United States Surgical, A Division of Tyco Healthc	1996	—
+1	K983296	Auto Suture Abbi System	United States Surgical, A Division of Tyco Healthc	1999	—
+2	K020031	EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006…	Neothermia Corp.	2002	—
+2	K011575	22MM Siteselect Breast Biopsy Device Model SSD022	Imagyn Surgical	2001	—
+3	K052246	Modification to EN-Bloc Biopsy System	Neothermia Corporation	2005	—
+2	K040087	Rabbit	Scion International, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	2	0
2004	1	0
2005	1	0

FIG. 1 — Lineage of K963825, 1987–2005Source: 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 KNW? 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 KNW device

#1 K260572 Marrow Marxmanscore 14.5 · 10 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
*	K871390	Bard Biopty Biopsy System Summary page 1 …nt for general use COMMON NAME: Biopsy Device PROPRIETARY NAME: Auto Suture* ABBI" Breast Biopsy System PREDICATE DEVICE: Bard® Biopty® Instrument Biopty-Cut® Needle (K871390). DEVICE DESCRIPTION: Both the Auto Suture* ABBI* Breast Biopsy System, and Bard® Biopty® Instrument Biopty-Cut® Needle (K871390…	C.R. Bard, Inc.	1987	—

Also cleared against K871390: 3 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K983296	Auto Suture Abbi System	United States Surgical, A Division of Tyco Healthc	1999	5
K020024	Caris Minitome Biopsy Instrument	Artemis Medical, Inc.	2002	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K983296 (United States Surgical, A Division of Tyco Healthc, 1999) has gone furthest, with 5 descendants of its own.
3 other devices also cite its predicate K871390.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNW

12in 2025

2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007high 203 (2022) · low 35 (2009)2026

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

Recalls per year · KNW

1in 2024

2007high 7 (2008) · low 0 (2015)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KNW

1,667in 2025

2007high 5,120 (2020) · low 67 (2011)2025

MAUDE reports naming product code KNW, 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	6	94	1	766
2008	4	53	7	363
2009	6	35	3	351
2010	3	57	2	162
2011	10	64	5	67
2012	7	94	1	93
2013	3	100	1 (1)	98
2014	8	95	3	193
2015	10	106	0	591
2016	9	127	5	297
2017	8	90	1	760
2018	7	71	0	1,012
2019	5	94	4	4,195
2020	8	92	0	5,120
2021	9	54	3	1,020
2022	8	203	3	535
2023	7	164	2	931
2024	5	114	1	1,283
2025	12	178	0	1,667
2026	7	29	4 (3)	—

What is it indicated for?

Like the Bard Biopsy Needle (K871390), the Auto Suture* ABBI* Breast Biopsy System is intended for obtaining biopsies from breast tissues for diagnostic purposes. The device is not intended for therapeutic excision of tissue.

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/K963825 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963825: Auto Suture* Abbi* System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963825

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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