Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Core Access Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) 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. The listed applicant is Core Access Surgical Technologies, Inc.. The 510(k) number is K212786.

When did LevaLap Laparoscopic Access Device receive FDA 510(k) clearance?

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

Who is the listed applicant for LevaLap Laparoscopic Access Device?

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

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

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

Related Devices (Code: HIF)

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.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

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.

↑