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)

TroKit Laparoscope Lens Wiper

K-Number: K253994 · 2026-06-04

ApplicantTroCare, LLC
Decision Date2026-06-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TroKit Laparoscope Lens Wiper is the device name listed in this FDA 510(k) record. The listed applicant is TroCare, LLC. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253994. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TroKit Laparoscope Lens Wiper?

TroKit Laparoscope Lens Wiper is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is TroCare, LLC. The 510(k) number is K253994.

When did TroKit Laparoscope Lens Wiper receive FDA 510(k) clearance?

TroKit Laparoscope Lens Wiper received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253994.

Who is the listed applicant for TroKit Laparoscope Lens Wiper?

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

What is the FDA product code for TroKit Laparoscope Lens Wiper?

The FDA product code for TroKit Laparoscope Lens Wiper is GCJ.

Other records listing TroCare, LLC 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.

K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)

Related Devices (Code: GCJ)

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.

K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.K252532Inno-Port Disposable Bladed TrocarTaiwan Surgical Corporation

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.

↑