510(k) · Cleared
ClearedThe Auto Suture* Mibb** 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 Dec 1, 1997 as substantially equivalent to K970565 (Biopsys Medical, Inc., 1997) after a 77-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 1, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970565 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970565 Mammotome Biopsy Probe and Housing (Mammotome)Biopsys Medical, Inc. · 1997
- This deviceK973496 The Auto Suture* Mibb** SystemUnited States Surgical, A Division of Tyco Healthc · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970565 | Mammotome Biopsy Probe and Housing (Mammotome) | Biopsys Medical, Inc. | 1997 | — |
| 0 (this device) | K973496 | The Auto Suture* Mibb** System | United States Surgical, A Division of Tyco Healthc | 1997 | — |
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 |
|---|---|---|---|
| * | K970565 | Mammotome Biopsy Probe and Housing (Mammotome)Summary page 1…d Statcs Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 Victor M. Clavelli September 8, 1997 Biopsy Instrument Biopsy Needle Not Yet Determined Mammotome® (K970565) The MIBB** system is comprised of a biopsy needle probe, a probc driver and a control module vacuum source. The MIBB** system i… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 2 other devices also cite its predicate K970565.
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?
The Auto Suture* MIBB** System has indication in incisional breast biopsy procedures for diagnostic purposes only and is not intended for therapeutic purposes.
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/K973496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973496: The Auto Suture* Mibb** System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973496
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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