510(k) · Cleared
Recalled · Class II · 2014Coramate/Spirotome System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medinvents · KNW Instrument, Biopsy
Cleared on Apr 11, 2008 as substantially equivalent to K896303 (Premier Medical, 1990) and 5 other predicates after an 88-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 11, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 2 generations to K033700 (2004). 6 ancestors in all, the oldest K842112 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK033700 Mammotome EX Hand Held SystemEthicon Endo-Surgery, Inc. · 2004 · Recalled
- 1 generation backK060384 Coramate/Spirotome SystemMedinvents · 2006 · Recalled
- This deviceK080095 Coramate/Spirotome SystemMedinvents · 2008
- Descendant · cites it directly · 0 of its ownK190378 Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14…Bioncise NV · 2019
Most influential descendants
Showing 1 of 1 · See all- K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome…Bioncise NV · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033700 | Mammotome EX Hand Held System | Ethicon Endo-Surgery, Inc. | 2004 | 1 |
| −1 | K060384 | Coramate/Spirotome System | Medinvents | 2006 | 1 |
| 0 (this device) | K080095 | Coramate/Spirotome System | Medinvents | 2008 | — |
| +1 | K190378 | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge… | Bioncise NV | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K896303 | Biopsy PunchSummary page 1…n Name: Biopsy Needle Predicate Devices: OISain Pre dev 1P7777777777Rmr Skin Punch Biopsy needle K896303 Spirotome (Easy Punch) Vulva Punch Biopsy needle K896030 Spirotome (Easy Punch) Breast… | 1990 |
| Kept off the family tree | K896030 | FDA’s K896030 is Hewlett-Packard Model M1016A CO2 & M1017A FI02 Our reading of the summary gave K896030, FDA’s number for Hewlett-Packard Model M1016A CO2 & M1017A FI02 (Hewlett-Packard Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Punch Biopsy needle”. Kept off the family tree. Summary page 1…1P7777777777Rmr Skin Punch Biopsy needle K896303 Spirotome (Easy Punch) Vulva Punch Biopsy needle K896030 Spirotome (Easy Punch) Breast Mammotome K033700 Spirotome/Coramate K060384 Lymph… | 1989 |
| * | K033700 | Mammotome EX Hand Held SystemSummary page 1…Spirotome (Easy Punch) Vulva Punch Biopsy needle K896030 Spirotome (Easy Punch) Breast Mammotome K033700 Spirotome/Coramate K060384 Lymph node Tru-cut needle K024120 Spirotome/Coramate Thyroid,… | 2004 |
| * | K060384 | Coramate/Spirotome SystemSummary page 1…Punch Biopsy needle K896030 Spirotome (Easy Punch) Breast Mammotome K033700 Spirotome/Coramate K060384 Lymph node Tru-cut needle K024120 Spirotome/Coramate Thyroid, salivary gland Tru-cut needle… | 2006 |
| * | K024120 | Modification to Temno Biopsy NeedlesSummary page 1…e (Easy Punch) Breast Mammotome K033700 Spirotome/Coramate K060384 Lymph node Tru-cut needle K024120 Spirotome/Coramate Thyroid, salivary gland Tru-cut needle K024120 Spirotome/Coramate Salivary gland… | 2003 |
| * | K842112 | Tischler Cervical Biopsy Punch ForcepsSummary page 1…K024120 Spirotome/Coramate Liver Tru-cut needle K024120 Spirotome/Coramate Cervix Forceps K842112 Spirotome Cervicore Muscle Tru-cut needle K024120 Spirotome/Coramate Abdominal wall… | 1984 |
| * | K001132 | Bone Biopsy NeedleSummary page 1…K024120 Spirotome/Coramate Thoracic wall Tru-cut needle K024120 Spirotome/Coramate Bone Bone marrow biopsy needle K001132 Spirotome Bone Device Description: The Coramate/Spirotome system is a mechanical biopsy device to harvest soft tissues from t… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190378 | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome… | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2014 | Class II | Z-0124-2015 | Package design/selection | MEDINVENTS, 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K190378 (Bioncise NV, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Coramate system is a core soft tissue biopsy medical devices to be used in humans to take out adequate samples from superficial soft tissues as breast, lymph nodes, thyroid, muscles, abdominal wall, thoracic wall and parotis. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Coramate system is intended to provide soft tissue for histological and…
Read the full statement (762 words)
The Coramate system is a core soft tissue biopsy medical devices to be used in humans to take out adequate samples from superficial soft tissues as breast, lymph nodes, thyroid, muscles, abdominal wall, thoracic wall and parotis.
The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities.
The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities.
An early detection and correct diagnosis of malignant disease is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient.
Incase of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.
The Spirotomne system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles and liver.
The Spirotomne system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities.
The Spirotomne system is intended to provide soft tissue for histological.and biomnolecular detection and confirmation of palpable abnormalities.
An early detection and correct diagnosis isa prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient.
In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.
The Cervicore system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the human cervix.
The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities by inspection or colposcopy.
The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities.
An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient.
Incase of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. Incase of benignancy, adequate follow-up of the patient can be provided.
The Easy Punch is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the skin.
The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities.
The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities.
An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient.
In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.
The Spirotome Bone is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from bony structures.
The Spirotome Bone is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities.
An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient.
In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. Incase of benignancy, adequate follow-up of the patient can be provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080095: Coramate/Spirotome System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080095
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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