Axcess Surgical Innovations, LLC

FDA Device Registration & Listing · Houston, TX, US · Registration 3015425104

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
3015425104
FEI Number
3015425104
Entity Name
Axcess Surgical Innovations, LLC
City/State/Country
Houston, TX, US
Establishment Address
10727 Kinghurst Drive, Houston, TX 77099, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
Axcess Surgical Innovations, LLC (Owner Number: 10038597)
Owner / Operator Contact Address
10727 Kinghurst Dr, Houston, TX 77099, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HOLDER, CAMERA, SURGICAL RETRACTOR, FIBEROPTIC INSTRUMENTS, SURGICAL, CARDIOVASCULAR Accessories, operating-room, table (kit) TRAY, SURGICAL INSTRUMENT, SURGICAL, NON-POWERED RETRACTOR, NON-SELF-RETAINING INSTRUMENT, MANUAL, SURGICAL, GENERAL USE RING, LAPAROTOMY RETRACTOR, SELF-RETAINING

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FXR Holder, Camera, Surgical General, Plastic Surgery Class 1 878.4160 2019-02-20
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2011-10-26
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2011-10-26
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2011-10-26
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2011-10-26
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2011-10-26
FGN Retractor, Non-Self-Retaining Gastroenterology, Urology Class 1 876.4730 2011-10-26
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2011-10-26
FHI Ring, Laparotomy Gastroenterology, Urology Class 1 876.4730 2011-10-26
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2011-10-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Axcess Surgical Innovations, LLC
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
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015425104. Last updated year: 2026. Please use registration number 3015425104 when referencing this establishment in official correspondence.
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