GASTRO CONCEPTS

FDA Device Registration & Listing · Albuquerque, NM, US · Registration 3034608931

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
3034608931
FEI Number
3034608931
Entity Name
GASTRO CONCEPTS
City/State/Country
Albuquerque, NM, US
Establishment Address
4425 Juan Tabo Blvd Ne Ste 104, Albuquerque, NM 87111, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Gastro Concepts (Owner Number: 10092252)
Owner / Operator Contact Address
4425 Juan Tabo NE, STE 104, Albuquerque, NM 87111, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242668
PMA Number
N/A

All Registered Proprietary Names

Air Assist

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2024-12-17
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-12-17

Official Correspondent

Jennifer Day

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gastro Concepts
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15

Similar Registrations

Registration Number Establishment Name Location
3016678045 Schneider ASR B.V. Rotterdam-Albrandswaard Zuid-Holland, NL
3012494290 SANICURE BV SCHIPHOL Noord-Holland, NL
3007388124 HAEMOBAND SURGICAL LTD Belfast Northern Ireland, GB
2027111 APPLIED MEDICAL RESOURCES CORP. RSM, CA, US
2032098 Isomedix Operations, Inc ONTARIO, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034608931. Last updated year: 2026. Please use registration number 3034608931 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.