Decision Date2023-11-30
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Benesta Tissue Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K233500. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Benesta Tissue Removal Device?
Benesta Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K233500.
When did Benesta Tissue Removal Device receive FDA 510(k) clearance?
Benesta Tissue Removal Device received FDA 510(k) clearance on 2023-11-30, under 510(k) number K233500.
Who is the listed applicant for Benesta Tissue Removal Device?
The FDA 510(k) record lists Caldera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Benesta Tissue Removal Device?
The FDA product code for Benesta Tissue Removal Device is HIH.
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Other records listing Caldera Medical, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemK192811BenestaTM Tissue Removal DeviceK192822Benesta HysteroscopeK193603Benesta Medical Sterilization TrayK191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackK172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left View all 20 devices →
Related Devices (Code: HIH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KGK261102UNIDRIVE Select SystemKarl Storz SE & CO. KGK254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.