510(k) · Cleared
ClearedAuto Suture Abbi System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · KNW Instrument, Biopsy
Cleared on Jun 4, 1999 as substantially equivalent to K963825 (United States Surgical, A Division of Tyco Healthc, 1996) after a 256-day review. Its family tree reaches back 2 generations to 1987. 5 later devices descend from it.
- Decided
- Jun 4, 1999
- Review
- 256 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871390 (1987). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 1 generation backK963825 Auto Suture* Abbi* SystemUnited States Surgical, A Division of Tyco Healthc · 1996
- This deviceK983296 Auto Suture Abbi SystemUnited States Surgical, A Division of Tyco Healthc · 1999
- Descendant · cites it directly · 1 of its ownK020031 EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002…Neothermia Corp. · 2002
- Descendant · cites it directly · 1 of its ownK011575 22MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001
- Descendant · 2 generations on · 0 of its ownK052246 Modification to EN-Bloc Biopsy SystemNeothermia Corporation · 2005
- Descendant · cites it directly · 0 of its ownK040087 RabbitScion International, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK020024 Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002
Most influential descendants
Showing 5 of 5 · See all- K020031EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302Neothermia Corp. · 2002 · cites it directly1descendant
- K01157522MM Siteselect Breast Biopsy Device Model SSD022Imagyn Surgical · 2001 · cites it directly1descendant
- K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation · 2005 · 2 generations on0descendants
- K040087RabbitScion International, Inc. · 2004 · cites it directly0descendants
- K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −1 | K963825 | Auto Suture* Abbi* System | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| 0 (this device) | K983296 | Auto Suture Abbi System | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| +1 | K020031 | EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006… | Neothermia Corp. | 2002 | — |
| +1 | K011575 | 22MM Siteselect Breast Biopsy Device Model SSD022 | Imagyn Surgical | 2001 | — |
| +2 | K052246 | Modification to EN-Bloc Biopsy System | Neothermia Corporation | 2005 | — |
| +1 | K040087 | Rabbit | Scion International, Inc. | 2004 | — |
| +1 | K020024 | Caris Minitome Biopsy Instrument | Artemis Medical, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K963825 | Auto Suture* Abbi* System Our OCR of the scanned summary read K963325, FDA’s number for Synthes Titanium (TI) Alloy High Tibial Osteotomy (Hto)… (Synthes (Usa)). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Auto Suture ABBI System”. | 1996 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K020031 (Neothermia Corp., 2002) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K963825.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 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?
To be used when stereotactically localized, large diameter, breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of 2 mammographic abnormality that i is suspicious for malignant disease (i.c. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of a histologic…
Read the full statement (148 words)
To be used when stereotactically localized, large diameter, breast biopsies, identified by the placement of a needle localization wire, are desired for diagnostic sampling of 2 mammographic abnormality that i is suspicious for malignant disease (i.c. usually BIRADS class 4 or 5). The ABBI* device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of a histologic abnormality cannot be determined from its mammographic appearance. Therefore, the extent of removal of a maromographic abnormality does not predict the extent of removal of a histologic abnormality, ¢.g., malignancy. When the sampled mammographic abnormality or the sampled tissue is not histologically Lenign, it is esscntial that the tissus margins be examined for completeness of removal.
The device is available in 3, 10, 15 and Z0mm diameters. Device diameter should be matched to desired diameter of tissue sample for diagnosis.
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/K983296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983296: 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/K983296
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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