Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LevaLap Laparoscopic Access Device

K-Number: K212786 · 2022-02-23

ApplicantCore Access Surgical Technologies, Inc.
Decision Date2022-02-23
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LevaLap Laparoscopic Access Device is a medical device manufactured by Core Access Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-23 under approval number K212786. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LevaLap Laparoscopic Access Device?

LevaLap Laparoscopic Access Device is a medical device that received FDA 510(k) clearance on 2022-02-23. It is manufactured by Core Access Surgical Technologies, Inc.. The 510(k) number is K212786.

When was LevaLap Laparoscopic Access Device approved by the FDA?

LevaLap Laparoscopic Access Device received FDA 510(k) clearance on 2022-02-23, under approval number K212786.

What company makes LevaLap Laparoscopic Access Device?

LevaLap Laparoscopic Access Device is manufactured by Core Access Surgical Technologies, Inc..

What is the FDA product code for LevaLap Laparoscopic Access Device?

The FDA product code for LevaLap Laparoscopic Access Device is HIF.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07262255 WATCHMAN FLX Pro European Registry RECRUITING NCT02438904 Compassionate Access of the Miltenyi Device for CD34+ Cell Selection RECRUITING NCT07110337 Diagnosing Epilepsy To EffeCT Change RECRUITING NCT07599085 Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41672626 [Regulatory Requirements and Considerations of Aesthetic Injection Medical Devices in China, the USA and the European Union]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41613088 Orphan medical devices: addressing the regulatory and access gaps in the EU and US. Frontiers in public health (2025) PMID: 41453730 Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for Poly (ADP-Ribose) Polymerase Inhibitor Access in Australia. The Journal of molecular diagnostics : JMD (2026)

Related Devices (Code: HIF)

K162648U-Blade Veress NeedleTianjin Uwell Medical Device Manufacturing Co., Ltd. K153367S698 Symbioz flowSopro - Acteon Group K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation KitFisher & Paykel Healthcare K171139LaparoLight Veress NeedleBuffalo Filter, LLC

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.

↑