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FDA 510(k)

Wiggins Medical Surgical Instruments

K-Number: K200383 · 2020-07-21

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

Device Summary

Wiggins Medical Surgical Instruments is a medical device manufactured by Wiggins Medical. It received FDA 510(k) clearance on 2020-07-21 under approval number K200383. 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 Wiggins Medical Surgical Instruments?

Wiggins Medical Surgical Instruments is a medical device that received FDA 510(k) clearance on 2020-07-21. It is manufactured by Wiggins Medical. The 510(k) number is K200383.

When was Wiggins Medical Surgical Instruments approved by the FDA?

Wiggins Medical Surgical Instruments received FDA 510(k) clearance on 2020-07-21, under approval number K200383.

What company makes Wiggins Medical Surgical Instruments?

Wiggins Medical Surgical Instruments is manufactured by Wiggins Medical.

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

The FDA product code for Wiggins 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Surgical Resectoscope Device RECRUITING NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient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: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (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) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 36976820 Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device. PloS one (2023)

Related Devices (Code: HAE)

K161744Symmetry Sharp Kerrison RongeurSymmetry Surgical, Inc. K153243Fehling-PunchesFehling Instruments GmbH & Co. KG K152734Kerrison RongeursVitalitec Medizintechnik GmbH K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG K180949SteribiteRjr Surgical, Inc. K200387Ace Medical Surgical InstrumentsAce Medical

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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