SAGE PRODUCT DEVELOPMENT, INC.

FDA Device Registration & Listing · Foxborough, MA, US · Registration 3014328942

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
3014328942
FEI Number
3014328942
Entity Name
SAGE PRODUCT DEVELOPMENT, INC.
City/State/Country
Foxborough, MA, US
Establishment Address
200 Foxborough Boulevard, suite 150, Foxborough, MA 02035, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Sage Product Development, Inc. (Owner Number: 10061421)
Owner / Operator Contact Address
200 Foxborough Boulevard, Foxborough, MA 02035, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CARTISTEM® Quickstitch SutureLock EndoFix Lucid Diagnostics Inc. CarpX TissueMil Base; TissueMil Skin Morcellation Device Bolt Navigation Device truCOLLECT device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTW Bit, Drill Orthopedic Class 1 888.4540 2026-03-31
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2026-02-10
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2026-02-10
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2026-02-10
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2019-11-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-05-11
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2025-07-15
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2022-12-19
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2025-03-04

Official Correspondent

Eliza Dhungana

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sage Product Development, Inc.
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
K082659 Covidien Lp, Formerly Registered AS United States MODIFIED ENDO STICH 2008-09-19
K902734 Olympus Corp. PR CANNULAS 1990-08-22
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011 Navilyst Medical, Inc 2
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014328942. Last updated year: 2026. Please use registration number 3014328942 when referencing this establishment in official correspondence.
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