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FDA 510(k)

TroCare TroKit Laparoscope Lens Wiper (CP000626)

K-Number: K241796 · 2024-10-04

ApplicantTroCare, LLC
Decision Date2024-10-04
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TroCare TroKit Laparoscope Lens Wiper (CP000626) is the device name listed in this FDA 510(k) record. The listed applicant is TroCare, LLC. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241796. 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 TroCare TroKit Laparoscope Lens Wiper (CP000626)?

TroCare TroKit Laparoscope Lens Wiper (CP000626) is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is TroCare, LLC. The 510(k) number is K241796.

When did TroCare TroKit Laparoscope Lens Wiper (CP000626) receive FDA 510(k) clearance?

TroCare TroKit Laparoscope Lens Wiper (CP000626) received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241796.

Who is the listed applicant for TroCare TroKit Laparoscope Lens Wiper (CP000626)?

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 TroCare TroKit Laparoscope Lens Wiper (CP000626)?

The FDA product code for TroCare TroKit Laparoscope Lens Wiper (CP000626) 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.

K253994TroKit Laparoscope Lens Wiper

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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