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FDA 510(k)

KOALA CLAMP

K-Number: K010695 · 2001-05-03

ApplicantMaternus, Inc.
Decision Date2001-05-03
Product CodeHFW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KOALA CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Maternus, Inc.. It received FDA 510(k) clearance on 2001-05-03 under 510(k) number K010695. The device is classified under product code HFW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOALA CLAMP?

KOALA CLAMP is a medical device that received FDA 510(k) clearance on 2001-05-03. The listed applicant is Maternus, Inc.. The 510(k) number is K010695.

When did KOALA CLAMP receive FDA 510(k) clearance?

KOALA CLAMP received FDA 510(k) clearance on 2001-05-03, under 510(k) number K010695.

Who is the listed applicant for KOALA CLAMP?

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

What is the FDA product code for KOALA CLAMP?

The FDA product code for KOALA CLAMP is HFW.

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 Maternus, 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.

K041332JOEY CLAMP OPENING TOOLK011621KOALA CLAMP, KOALA CLAMP AND CUTTER

Related Devices (Code: HFW)

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.

K041332JOEY CLAMP OPENING TOOLMaternus, Inc.K033846KAEN YIH UMBILICAL CORD CLAMPKaen Yih Enterprise Co., Ltd.K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEPrecision Dynamics Corp.K021055BUSSE UMBILICAL CORD CLAMP CUTTERBusse Hospital Disposables, Inc.K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BDynarex Corp.K011621KOALA CLAMP, KOALA CLAMP AND CUTTERMaternus, Inc.

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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