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FDA 510(k)

ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)

K-Number: K011369 · 2001-05-29

ApplicantSafety Syringes, Inc.
Decision Date2001-05-29
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) is the device name listed in this FDA 510(k) record. The listed applicant is Safety Syringes, Inc.. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K011369. 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 ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)?

ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Safety Syringes, Inc.. The 510(k) number is K011369.

When did ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) receive FDA 510(k) clearance?

ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) received FDA 510(k) clearance on 2001-05-29, under 510(k) number K011369.

Who is the listed applicant for ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)?

The FDA 510(k) record lists Safety Syringes, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)?

The FDA product code for ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) is MEG.

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Other records listing Safety Syringes, Inc. 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.

K123743ULTRASAFE PLUS PASSIVE NEEDLE GUARDK122558ULTRASAFE PASSIVE NEEDLE GUARDK060743MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)K042712TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEMK013801ULTRASAFE DENTAL INJECTION SYSTEMK972877ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD

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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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