FDA 510(k)

MODIFICATION TO STRYKER PAINPUMP

K-Number: K031249 · 2003-07-21

Decision Date2003-07-21

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO STRYKER PAINPUMP is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2003-07-21 under 510(k) number K031249. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO STRYKER PAINPUMP?

MODIFICATION TO STRYKER PAINPUMP is a medical device that received FDA 510(k) clearance on 2003-07-21. The listed applicant is Stryker Instruments. The 510(k) number is K031249.

When did MODIFICATION TO STRYKER PAINPUMP receive FDA 510(k) clearance?

MODIFICATION TO STRYKER PAINPUMP received FDA 510(k) clearance on 2003-07-21, under 510(k) number K031249.

Who is the listed applicant for MODIFICATION TO STRYKER PAINPUMP?

The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO STRYKER PAINPUMP?

The FDA product code for MODIFICATION TO STRYKER PAINPUMP is FRN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Stryker Instruments as applicant

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)K261544Hydro Irrigation System K253679Hydro Irrigation System K252282SurgiCount+ System K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer K250483PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

View all 75 devices →

Related Devices (Code: FRN)

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.