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FDA 510(k)

Ace Medical Surgical Instruments

K-Number: K200387 · 2020-07-21

ApplicantAce Medical
Decision Date2020-07-21
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ace Medical Surgical Instruments is a medical device manufactured by Ace Medical. It received FDA 510(k) clearance on 2020-07-21 under approval number K200387. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ace Medical Surgical Instruments?

Ace Medical Surgical Instruments is a medical device that received FDA 510(k) clearance on 2020-07-21. It is manufactured by Ace Medical. The 510(k) number is K200387.

When was Ace Medical Surgical Instruments approved by the FDA?

Ace Medical Surgical Instruments received FDA 510(k) clearance on 2020-07-21, under approval number K200387.

What company makes Ace Medical Surgical Instruments?

Ace Medical Surgical Instruments is manufactured by Ace Medical.

What is the FDA product code for Ace Medical Surgical Instruments?

The FDA product code for Ace Medical Surgical Instruments is HAE.

Related Clinical Trials

NCT04235764 En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device RECRUITING NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING

Related PubMed Literature

PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Related Devices (Code: HAE)

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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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