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FDA 510(k)

EXEL SECURE TOUCH II SAFETY SYRINGE

K-Number: K052103 · 2005-10-19

ApplicantExelint Intl. Co.
Decision Date2005-10-19
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXEL SECURE TOUCH II SAFETY SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Exelint Intl. Co.. It received FDA 510(k) clearance on 2005-10-19 under 510(k) number K052103. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXEL SECURE TOUCH II SAFETY SYRINGE?

EXEL SECURE TOUCH II SAFETY SYRINGE is a medical device that received FDA 510(k) clearance on 2005-10-19. The listed applicant is Exelint Intl. Co.. The 510(k) number is K052103.

When did EXEL SECURE TOUCH II SAFETY SYRINGE receive FDA 510(k) clearance?

EXEL SECURE TOUCH II SAFETY SYRINGE received FDA 510(k) clearance on 2005-10-19, under 510(k) number K052103.

Who is the listed applicant for EXEL SECURE TOUCH II SAFETY SYRINGE?

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

What is the FDA product code for EXEL SECURE TOUCH II SAFETY SYRINGE?

The FDA product code for EXEL SECURE TOUCH II SAFETY SYRINGE is MEG.

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Other records listing Exelint Intl. 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.

K092172EXEL I.V. EXTENSION SETK031500EXCEL PRIMARY SOLUTION SETK011754EXEL SECURETOUCH PTP SYRINGEK020533EXEL VACULET BLOOD COLLECTION SETK022406EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SETK011757EXEL COMFORTPOINT INSULIN PEN NEEDLE

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Related Devices (Code: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

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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