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FDA 510(k)

IMPOWER EXTERNAL VACUUM SYSTEM

K-Number: K980291 · 1998-03-11

ApplicantImagyn Medical Technologies, Inc.
Decision Date1998-03-11
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMPOWER EXTERNAL VACUUM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical Technologies, Inc.. It received FDA 510(k) clearance on 1998-03-11 under 510(k) number K980291. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPOWER EXTERNAL VACUUM SYSTEM?

IMPOWER EXTERNAL VACUUM SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-11. The listed applicant is Imagyn Medical Technologies, Inc.. The 510(k) number is K980291.

When did IMPOWER EXTERNAL VACUUM SYSTEM receive FDA 510(k) clearance?

IMPOWER EXTERNAL VACUUM SYSTEM received FDA 510(k) clearance on 1998-03-11, under 510(k) number K980291.

Who is the listed applicant for IMPOWER EXTERNAL VACUUM SYSTEM?

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

What is the FDA product code for IMPOWER EXTERNAL VACUUM SYSTEM?

The FDA product code for IMPOWER EXTERNAL VACUUM SYSTEM is LKY.

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Other records listing Imagyn Medical Technologies, 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.

K032491ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITORK012706IM2001 PULSE OXIMETERK010166IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEMK991526ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501K980096OAC (OPTICAL ASPIRATING CURETTE)K974173ERECAID SYSTEM/STAY EREC SYSTEM

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Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., 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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