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FDA 510(k)

OpClear System

K-Number: K171637 · 2018-02-26

ApplicantCipher Surgical, Ltd.
Decision Date2018-02-26
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OpClear System is the device name listed in this FDA 510(k) record. The listed applicant is Cipher Surgical, Ltd.. It received FDA 510(k) clearance on 2018-02-26 under 510(k) number K171637. 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 OpClear System?

OpClear System is a medical device that received FDA 510(k) clearance on 2018-02-26. The listed applicant is Cipher Surgical, Ltd.. The 510(k) number is K171637.

When did OpClear System receive FDA 510(k) clearance?

OpClear System received FDA 510(k) clearance on 2018-02-26, under 510(k) number K171637.

Who is the listed applicant for OpClear System?

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

What is the FDA product code for OpClear System?

The FDA product code for OpClear System is OCX.

Other records listing Cipher Surgical, Ltd. 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.

K221824OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315

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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