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FDA 510(k)

SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES

K-Number: K983858 · 1999-01-29

ApplicantSims Portex, Inc.
Decision Date1999-01-29
Product CodeMIA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex, Inc.. It received FDA 510(k) clearance on 1999-01-29 under 510(k) number K983858. The device is classified under product code MIA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES?

SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES is a medical device that received FDA 510(k) clearance on 1999-01-29. The listed applicant is Sims Portex, Inc.. The 510(k) number is K983858.

When did SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES receive FDA 510(k) clearance?

SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES received FDA 510(k) clearance on 1999-01-29, under 510(k) number K983858.

Who is the listed applicant for SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES?

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

What is the FDA product code for SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES?

The FDA product code for SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES is MIA.

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Other records listing Sims Portex, 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.

K011925HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIOK002201ELECTROSTATIC HYDROPHOBIC BREATHING FILTERK002506BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUITK001318CPAP SYSTEM, MODEL 102001K993619CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCKK994275SIMS PORTEX ANESTHESIA CATHETER

View all 12 devices →

Related Devices (Code: MIA)

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.

K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectorsSmiths Medical Asd, Inc.K051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837Epimed International, Inc.K982269CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GAAllegiance Healthcare Corp.K971645REGANES SPINAL NEEDLE (VARIOUS)Avid N.I.T., Inc.K970997NEO-CARE LUMBER PUNCTURE KITKlein-Baker Medical, Inc.K961324GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLESGlobal Medical Prods, 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.

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