CS-05-30-290 OpClear Disposable

FDA UDI

Class II (US FDA UDI)

by Cipher Surgical, Ltd.

Identity

Trade Name: CS-05-30-290 OpClear Disposable FDA UDI
Generic Name: Endoscope lens cleaner, gas/fluid, single-use FDA UDI
Device Name: The OpClear Disposable is a 5mm (Diameter) x 290mm (L) x angled (30 and 45 degrees compatible) sterile, invasive, single use device which is fitted to a compatible laparoscope and used with the OpClear Control Unit. FDA UDI
Model / Reference: CS-05-30-290 FDA UDI
Description: The OpClear Disposable is a 5mm (Diameter) x 290mm (L) x angled (30 and 45 degrees compatible) sterile, invasive, single use device which is fitted to a compatible laparoscope and used with the OpClear Control Unit. FDA UDI

Identifiers

Catalog Number: CS-05-30-290 FDA UDI
Primary DI / UDI-DI: 50603468009056 FDA UDI
510(k) Number: K221824 FDA UDI
FDA Product Code: FEQ FDA UDI
OCX FDA UDI
GMDN Term: Endoscope lens cleaner, gas/fluid, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscope lens cleaner, gas/fluid, single-use Surgical irrigation pump

CS-05-30-290 OpClear Disposable by Cipher Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K221824 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cipher Surgical, Ltd.

Sources (1)

FDA UDI edbf0aec-4de6-459f-9358-9949a9c857aa 37 fields · synced May 30, 2026