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FDA 510(k)

THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM

K-Number: K010692 · 2001-06-29

ApplicantSpintech, Inc.
Decision Date2001-06-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spintech, Inc.. It received FDA 510(k) clearance on 2001-06-29 under 510(k) number K010692. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM?

THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-29. The listed applicant is Spintech, Inc.. The 510(k) number is K010692.

When did THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM receive FDA 510(k) clearance?

THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM received FDA 510(k) clearance on 2001-06-29, under 510(k) number K010692.

Who is the listed applicant for THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM?

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

What is the FDA product code for THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM?

The FDA product code for THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM is FMF.

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Other records listing Spintech, 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.

K223079StageK210843STAGEK173224SPIN-SWIK023722SAFETYWAND DISPOSABLE HANDPIECEK992404THE WANDK992819WAND PLUS

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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