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SOLAR Anorectal Manometry Catheter

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Corp.

Identity

Trade Name
SOLAR Anorectal Manometry Catheter FDA UDI
Generic Name
Gastrointestinal motility manometric catheter, electronic FDA UDI
Device Name
SOLAR Anorectal Manometry Catheter FDA UDI
Model / Reference
K1210AC-L-2212 FDA UDI
Description
SOLAR Anorectal Manometry Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00627825014830 FDA UDI
510(k) Number
K234107 FDA UDI
FDA Product Code
KLA FDA UDI
GMDN Term
Gastrointestinal motility manometric catheter, electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrointestinal motility manometric catheter, electronic

SOLAR Anorectal Manometry Catheter by Laborie Medical Technologies Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal motility manometric catheter, electronic.

Cleared under the same submission

K234107 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Laborie Medical Technologies Corp.

Sources (1)

  • FDA UDI 8cd57b8d-6250-4933-bb56-399de850d7f3 34 fields · synced Jun 9, 2026