Decision Date2003-05-30
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
STRYKER PAINPUMP2 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2003-05-30 under 510(k) number K030661. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the STRYKER PAINPUMP2?
STRYKER PAINPUMP2 is a medical device that received FDA 510(k) clearance on 2003-05-30. The listed applicant is Stryker Instruments. The 510(k) number is K030661.
When did STRYKER PAINPUMP2 receive FDA 510(k) clearance?
STRYKER PAINPUMP2 received FDA 510(k) clearance on 2003-05-30, under 510(k) number K030661.
Who is the listed applicant for STRYKER PAINPUMP2?
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 STRYKER PAINPUMP2?
The FDA product code for STRYKER PAINPUMP2 is MEA.
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.
Other records listing Stryker Instruments as applicant
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.
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 SystemK253679Hydro Irrigation SystemK252282SurgiCount+ SystemK251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerK250483PhotonBlade 3; PhotonBlade 3 Smoke Evacuation View all 75 devices →
Related Devices (Code: MEA)
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.
K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc.K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)Smiths Medical Ads, Inc.K143612LifeCare PCA Infusion SystemHospira, Inc.K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0Smiths Medical Asd, Inc.K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMB.Braun Medical, Inc.K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORSmiths Medical MD, 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.