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FDA 510(k)

FEMTEN CERVICAL TENACULUM

K-Number: K062563 · 2007-05-18

ApplicantFem Suite, LLC
Decision Date2007-05-18
Product CodeHDC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMTEN CERVICAL TENACULUM is the device name listed in this FDA 510(k) record. The listed applicant is Fem Suite, LLC. It received FDA 510(k) clearance on 2007-05-18 under 510(k) number K062563. The device is classified under product code HDC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMTEN CERVICAL TENACULUM?

FEMTEN CERVICAL TENACULUM is a medical device that received FDA 510(k) clearance on 2007-05-18. The listed applicant is Fem Suite, LLC. The 510(k) number is K062563.

When did FEMTEN CERVICAL TENACULUM receive FDA 510(k) clearance?

FEMTEN CERVICAL TENACULUM received FDA 510(k) clearance on 2007-05-18, under 510(k) number K062563.

Who is the listed applicant for FEMTEN CERVICAL TENACULUM?

The FDA 510(k) record lists Fem Suite, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMTEN CERVICAL TENACULUM?

The FDA product code for FEMTEN CERVICAL TENACULUM is HDC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fem Suite, LLC 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.

K093218FEMEYE TWO

Related Devices (Code: HDC)

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.

K223866Carevix™ Suction Cervical StabilizerAspivix SAK203820ASPIVIX v1.1 Cervical Suction TenaculumAspivix SAK082349JARIT HULKA UTERINE TENACULUM FORCEPSJ. Jamner Surgical Instruments, Inc.K073182GYN DISPOSABLES TENACULUM 356TGyn-Disposables, Inc.K060573BURBANK TENACULUMVascular Control Systems, Inc.K032585TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEMRon-Tech Medical , 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.

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