Device
A portable digital rectoscope enabling rapid, real-time colorectal diagnosis.
Manufacturer
SURGEASE INNOVATIONS LIMITED
SURGEASE INNOVATIONS LIMITED
Model: LX1-SCP-203
Catalog: LX1-SCP-203
DI: 05060768280286
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
A portable digital rectoscope enabling rapid, real-time colorectal diagnosis.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d8481cd0-9434-41c0-a97c-3ebb3415692f
Distribution Status:
In Commercial Distribution
DUNS Number:
221628713
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05060768280286
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36635
Name: Rigid optical rectoscope, reusable
Definition:
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during rectoscopy. Anatomical images are transmitted to the user typically through relayed lens optics. This device is longer than a proctoscope to provide a deeper view and it is typically equipped with illumination in the distal end. It is typically used to examine the structures of the rectum for irregularities. This is a reusable device.
FDA Product Codes
FAN
Sigmoidoscope, Rigid, Electrical
Premarket Submissions
Submission Number:
K232262
Supplement Number:
000