# K080095: Coramate/Spirotome System - Pathway: 510(k) (Traditional) - Applicant: Medinvents - Decided: Apr 11, 2008 after 88 days - Product code: KNW (Instrument, Biopsy) - Device class: 2 - Regulation: 21 CFR 876.1075 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K033700 (2004). 6 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 8 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K896303: Biopsy Punch, Premier Medical (1990) Summary page 1. - K033700: Mammotome EX Hand Held System, Ethicon Endo-Surgery, Inc. (2004) Summary page 1. - K060384: Coramate/Spirotome System, Medinvents (2006) Summary page 1. - K024120: Modification to Temno Biopsy Needles, Allegiance Healthcare Corp. (2003) Summary page 1. - K842112: Tischler Cervical Biopsy Punch Forceps, J. Sklar Mfg. Co., Inc. (1984) Summary page 1. - K001132: Bone Biopsy Needle, Promex, Inc. (2000) Summary page 1. ## Cited in the summary but kept off the family tree - K896030: Hewlett-Packard Model M1016A CO2 & M1017A FI02, Hewlett-Packard Co. (1989). 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. ## Most influential descendants - K190378: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix (2019), 0 descendants of its own ## Recalls of this device - Sep 26, 2014 · Class II · Z-0124-2015: 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 custo ## Indications for use 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. Source page: https://510kreport.com/device/K080095 Methodology: https://510kreport.com/methodology