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FDA 510(k)

SYREX PRE-FILLED SYRINGE

K-Number: K023740 · 2003-05-13

ApplicantExcelsior Medical Corp.
Decision Date2003-05-13
Product CodeNZW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYREX PRE-FILLED SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Excelsior Medical Corp.. It received FDA 510(k) clearance on 2003-05-13 under 510(k) number K023740. The device is classified under product code NZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYREX PRE-FILLED SYRINGE?

SYREX PRE-FILLED SYRINGE is a medical device that received FDA 510(k) clearance on 2003-05-13. The listed applicant is Excelsior Medical Corp.. The 510(k) number is K023740.

When did SYREX PRE-FILLED SYRINGE receive FDA 510(k) clearance?

SYREX PRE-FILLED SYRINGE received FDA 510(k) clearance on 2003-05-13, under 510(k) number K023740.

Who is the listed applicant for SYREX PRE-FILLED SYRINGE?

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

What is the FDA product code for SYREX PRE-FILLED SYRINGE?

The FDA product code for SYREX PRE-FILLED SYRINGE is NZW.

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Other records listing Excelsior Medical Corp. 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.

K130975SWABCAP AND SWABFLUSHK101270SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311K083508SWABCAPK082837STERILE FIELD SALINE PRE-FILLED SYRINGE(S)K061497SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/MLK053120STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES

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Related Devices (Code: NZW)

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.

K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and CompanyK092938HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710App Pharmaceuticals, LLCK092491MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZESMedefil, Inc.K090680HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGEBecton, Dickinson & COK061497SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/MLExcelsior Medical Corp.

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.

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