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FDA 510(k)

INSTA-FLO

K-Number: K935209 · 1993-12-13

ApplicantMedtec, Inc.
Decision Date1993-12-13
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSTA-FLO is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc.. It received FDA 510(k) clearance on 1993-12-13 under 510(k) number K935209. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTA-FLO?

INSTA-FLO is a medical device that received FDA 510(k) clearance on 1993-12-13. The listed applicant is Medtec, Inc.. The 510(k) number is K935209.

When did INSTA-FLO receive FDA 510(k) clearance?

INSTA-FLO received FDA 510(k) clearance on 1993-12-13, under 510(k) number K935209.

Who is the listed applicant for INSTA-FLO?

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

What is the FDA product code for INSTA-FLO?

The FDA product code for INSTA-FLO is JAD.

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Other records listing Medtec, Inc. as applicant

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K111340HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEMK093738MRI PATIENT POSITIONING DEVICESK974703CARBON FIBER BREAST BOARDK974700MATRIX MT-MX3K973842CARBON FIBER CONFORMAL COUCH TOPK962622INTRA-ORAL THERMOPLASTIC SHIELD

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Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, 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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