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)

SOLOPAK BRAND FILTER NEEDLE W/5 MICRO

K-Number: K841280 · 1984-05-21

ApplicantSmith & Nephew, Mpl Division
Decision Date1984-05-21
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOLOPAK BRAND FILTER NEEDLE W/5 MICRO is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Mpl Division. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K841280. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLOPAK BRAND FILTER NEEDLE W/5 MICRO?

SOLOPAK BRAND FILTER NEEDLE W/5 MICRO is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Smith & Nephew, Mpl Division. The 510(k) number is K841280.

When did SOLOPAK BRAND FILTER NEEDLE W/5 MICRO receive FDA 510(k) clearance?

SOLOPAK BRAND FILTER NEEDLE W/5 MICRO received FDA 510(k) clearance on 1984-05-21, under 510(k) number K841280.

Who is the listed applicant for SOLOPAK BRAND FILTER NEEDLE W/5 MICRO?

The FDA 510(k) record lists Smith & Nephew, Mpl Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLOPAK BRAND FILTER NEEDLE W/5 MICRO?

The FDA product code for SOLOPAK BRAND FILTER NEEDLE W/5 MICRO is FPB.

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 Smith & Nephew, Mpl Division 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.

K843314MPL HYPO BRAND BREECH LOAD ASPIR SYRINGEK840237MAX-I-PROBE PERIODONTAL ENDODONTIC PROBK833304HYPO BRAND DISPOS. DENTAL NEEDLES-PLASTK832126MICRO Z DISPOS. SPINAL ANESTH. NEEDLEK831765HERAPIN LOCK FLUSH SOLUTION USE KITK830524HENKE JECT PRESSURE SYRINGE

View all 9 devices →

Related Devices (Code: FPB)

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.

K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA, LLCK233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare CorpK021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.K993379PALL SUPOR AEF FILTERPall Corp.K9746610.2 U BACTERIAL FILTERSims Deltec, 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.

↑