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FDA 510(k)

Saneso Lens Wash Bottle Assembly (SAN-LWB-A)

K-Number: K222173 · 2023-02-27

ApplicantSaneso, Inc.
Decision Date2023-02-27
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is the device name listed in this FDA 510(k) record. The listed applicant is Saneso, Inc.. It received FDA 510(k) clearance on 2023-02-27 under 510(k) number K222173. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Saneso Lens Wash Bottle Assembly (SAN-LWB-A)?

Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is a medical device that received FDA 510(k) clearance on 2023-02-27. The listed applicant is Saneso, Inc.. The 510(k) number is K222173.

When did Saneso Lens Wash Bottle Assembly (SAN-LWB-A) receive FDA 510(k) clearance?

Saneso Lens Wash Bottle Assembly (SAN-LWB-A) received FDA 510(k) clearance on 2023-02-27, under 510(k) number K222173.

Who is the listed applicant for Saneso Lens Wash Bottle Assembly (SAN-LWB-A)?

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

What is the FDA product code for Saneso Lens Wash Bottle Assembly (SAN-LWB-A)?

The FDA product code for Saneso Lens Wash Bottle Assembly (SAN-LWB-A) is OCX.

Other records listing Saneso, Inc. 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.

K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))

Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, Inc.

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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