510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Coramate/Spirotome System

K060384510(k) TraditionalCleared Jul 13, 2006149-day reviewClass II21 CFR 876.1075Recalls 1

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

Medinvents · KNW Instrument, Biopsy

Cleared on Jul 13, 2006 as substantially equivalent to K033700 (Ethicon Endo-Surgery, Inc., 2004) after a 149-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it. It has been recalled once.

Decided
Jul 13, 2006
Review
149 days
Class
Class II
Product code
KNW
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K033700 (2004). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2019: 1 descendant clearedK033700 · Mammotome EX Hand Held System · Ethicon Endo-Surgery, Inc. · 2004 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K033700 · Mammotome EX Hand Held System · Ethicon Endo-Surgery, Inc. · 2004 · recalled0
  1. Root · 1 generation backK033700 Mammotome EX Hand Held SystemEthicon Endo-Surgery, Inc. · 2004 · Recalled
  2. This deviceK060384 Coramate/Spirotome SystemMedinvents · 2006
  3. Descendant · cites it directly · 1 of its ownK080095 Coramate/Spirotome SystemMedinvents · 2008 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK190378 Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14…Bioncise NV · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K080095Coramate/Spirotome SystemMedinvents · 2008 · cites it directly1descendant
  • K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome…Bioncise NV · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K033700Mammotome EX Hand Held SystemEthicon Endo-Surgery, Inc.20041
0 (this device)K060384Coramate/Spirotome SystemMedinvents2006—
+1K080095Coramate/Spirotome SystemMedinvents20081
+2K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge…Bioncise NV2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201910
FIG. 1 — Lineage of K060384, 2004–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K033700Mammotome EX Hand Held System
Summary page 1
…epared: April 4, 2006 2. Device Name: Trade Name: Coramate/Spirotome system Classification Name: Biopsy Needle 3. Predicate Device: The Mammotome Biopsy System (K033700) is substantially equivalent to other biopsy needle systems on the market, including the Coramate/Spirotome system. 4. Device…
Ethicon Endo-Surgery, Inc.20041

Also cleared against K033700: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080095Coramate/Spirotome SystemMedinvents20081

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 26, 2014Class IIZ-0124-2015Package design/selectionMEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K080095 (Medinvents, 2008) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K033700.

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

2007: 62008: 42009: 62010: 32011: 102012: 72013: 32014: 82015: 102016: 92017: 82018: 72019: 52020: 82021: 92022: 82023: 72024: 52025: 122026 (partial year): 7
2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007: 94 days median2008: 53 days median2009: 35 days median2010: 57 days median2011: 64 days median2012: 94 days median2013: 100 days median2014: 95 days median2015: 106 days median2016: 127 days median2017: 90 days median2018: 71 days median2019: 94 days median2020: 92 days median2021: 54 days median2022: 203 days median2023: 164 days median2024: 114 days median2025: 178 days median2026 (partial year): 29 days median
2007high 203 (2022) · low 35 (2009)2026

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

Recalls per year · KNW

1in 2024

2007: 12008: 72009: 32010: 22011: 52012: 12013: 1, 1 Class I2014: 32016: 52017: 12019: 42021: 32022: 32023: 22024: 12026 (partial year): 4, 3 Class I
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

2007: 7662008: 3632009: 3512010: 1622011: 672012: 932013: 982014: 1932015: 5912016: 2972017: 7602018: 1,0122019: 4,1952020: 5,1202021: 1,0202022: 5352023: 9312024: 1,2832025: 1,667
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076941766
20084537363
20096353351
20103572162
20111064567
2012794193
201331001 (1)98
20148953193
2015101060591
201691275297
20178901760
201877101,012
201959444,195
202089205,120
202195431,020
202282033535
202371642931
2024511411,283
20251217801,667
20267294 (3)—

What is it indicated for?

The Coramate/Spirotome system is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. The Coramate/Spirotome system is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.…

Read the full statement (129 words)

The Coramate/Spirotome system is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Coramate/Spirotome system is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K033700

4 other devices cite the same predicate.

  • K152989Mammotome revolve Dual Vacuum Assist Biopsy SystemDevicor Medical Products, Inc. · 20161 recall
  • K123259Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) SystemDevicor Medical Products, Inc. · 20121 recall
  • K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc. · 2012
  • K080095Coramate/Spirotome SystemMedinvents · 20081 recall

More from Medinvents

2 FDA decisions under this applicant name. See the company

  • K080095Coramate/Spirotome SystemMedinvents · 20081 recall

Recent decisions in KNW

The KNW category page

  • K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
  • K260572Marrow MarxmanMedimetrix, LLC · 2026
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026

https://510kreport.com/device/K060384 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060384: Coramate/Spirotome System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060384

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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