Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IRRIGATION SET W/PISTON SYRINGE

K-Number: K803198 · 1981-01-15

ApplicantWalpak Co.
Decision Date1981-01-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IRRIGATION SET W/PISTON SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Walpak Co.. It received FDA 510(k) clearance on 1981-01-15 under 510(k) number K803198. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION SET W/PISTON SYRINGE?

IRRIGATION SET W/PISTON SYRINGE is a medical device that received FDA 510(k) clearance on 1981-01-15. The listed applicant is Walpak Co.. The 510(k) number is K803198.

When did IRRIGATION SET W/PISTON SYRINGE receive FDA 510(k) clearance?

IRRIGATION SET W/PISTON SYRINGE received FDA 510(k) clearance on 1981-01-15, under 510(k) number K803198.

Who is the listed applicant for IRRIGATION SET W/PISTON SYRINGE?

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

What is the FDA product code for IRRIGATION SET W/PISTON SYRINGE?

The FDA product code for IRRIGATION SET W/PISTON SYRINGE is FMF.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Walpak Co. 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.

K803200IRRIGATION SET W/BULB SYRINGEK803204IRRIGATION PISTONK803199SUTURE REMOVAL KITK803201LEMON GLYCERINE SWABSK802083CATHETER INSERTION TRAYK791598CLOSED SYSTEM FOLEY CATHERIZATION PROCED

View all 11 devices →

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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.

↑