CIPHER SURGICAL LTD

FDA Device Registration & Listing · Coventry, GB · Registration 3013348547

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013348547
FEI Number
3013348547
Entity Name
CIPHER SURGICAL LTD
City/State/Country
Coventry, GB
Establishment Address
The Venture Centre, Sir William Lyons Road, Coventry CV4 7EZ, GB
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Cipher Surgical Ltd (Owner Number: 10060194)
Owner / Operator Contact Address
The Venture Centre, Sir William Lyons Road, Coventry, GB-COV CV4 7EZ, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221824
PMA Number
N/A

All Registered Proprietary Names

OpClear® Disposable Procedure Kit OpClear® Control Unit OpClear® Disposable OpClear® Platform CS-CU15-03 OpClear® OpClear® System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2022-12-15
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2022-12-15

Official Correspondent

Andrew Newell

US Agent Details

Manny Sok Business: Medical Solutions Inc. Email: msok@msi-healthcare.com Phone: (703) 9957104

Related Public Records

Same Entity

Cipher Surgical Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023 Hobbs Medical, Inc. 2
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013348547. Last updated year: 2026. Please use registration number 3013348547 when referencing this establishment in official correspondence.
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