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FDA 510(k)

OAC (OPTICAL ASPIRATING CURETTE)

K-Number: K980096 · 1998-05-01

ApplicantImagyn Medical Technologies, Inc.
Decision Date1998-05-01
Product CodeHCY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OAC (OPTICAL ASPIRATING CURETTE) 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 1998-05-01 under 510(k) number K980096. The device is classified under product code HCY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OAC (OPTICAL ASPIRATING CURETTE)?

OAC (OPTICAL ASPIRATING CURETTE) is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Imagyn Medical Technologies, Inc.. The 510(k) number is K980096.

When did OAC (OPTICAL ASPIRATING CURETTE) receive FDA 510(k) clearance?

OAC (OPTICAL ASPIRATING CURETTE) received FDA 510(k) clearance on 1998-05-01, under 510(k) number K980096.

Who is the listed applicant for OAC (OPTICAL ASPIRATING CURETTE)?

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 OAC (OPTICAL ASPIRATING CURETTE)?

The FDA product code for OAC (OPTICAL ASPIRATING CURETTE) is HCY.

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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-12501K980291IMPOWER EXTERNAL VACUUM SYSTEMK974173ERECAID SYSTEM/STAY EREC SYSTEM

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Related Devices (Code: HCY)

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.

K944238ENDOCYTE TMD.L. Nelson and Assoc., Inc.K935822PHASE I CURETTEPhase I Corp.K901442BAXTER D & C TRAYBaxter Healthcare CorpK890384UTERINE CURETTEKinetic Medical ProductsK881794IVORY FINDER SETIvory Instruments Co.K862297THE D & C PAD-SACNu-Gyn-Tek, 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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