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FDA 510(k)

THE D & C PAD-SAC

K-Number: K862297 · 1986-07-07

ApplicantNu-Gyn-Tek, Inc.
Decision Date1986-07-07
Product CodeHCY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THE D & C PAD-SAC is the device name listed in this FDA 510(k) record. The listed applicant is Nu-Gyn-Tek, Inc.. It received FDA 510(k) clearance on 1986-07-07 under 510(k) number K862297. 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 THE D & C PAD-SAC?

THE D & C PAD-SAC is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is Nu-Gyn-Tek, Inc.. The 510(k) number is K862297.

When did THE D & C PAD-SAC receive FDA 510(k) clearance?

THE D & C PAD-SAC received FDA 510(k) clearance on 1986-07-07, under 510(k) number K862297.

Who is the listed applicant for THE D & C PAD-SAC?

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

What is the FDA product code for THE D & C PAD-SAC?

The FDA product code for THE D & C PAD-SAC is HCY.

Other records listing Nu-Gyn-Tek, 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.

K900759POLY-OP (TM)

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.

K980096OAC (OPTICAL ASPIRATING CURETTE)Imagyn Medical Technologies, Inc.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.

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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