Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POLY-OP (TM)

K-Number: K900759 · 1990-05-24

ApplicantNu-Gyn-Tek, Inc.
Decision Date1990-05-24
Product CodeOCF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POLY-OP (TM) 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 1990-05-24 under 510(k) number K900759. The device is classified under product code OCF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-OP (TM)?

POLY-OP (TM) is a medical device that received FDA 510(k) clearance on 1990-05-24. The listed applicant is Nu-Gyn-Tek, Inc.. The 510(k) number is K900759.

When did POLY-OP (TM) receive FDA 510(k) clearance?

POLY-OP (TM) received FDA 510(k) clearance on 1990-05-24, under 510(k) number K900759.

Who is the listed applicant for POLY-OP (TM)?

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 POLY-OP (TM)?

The FDA product code for POLY-OP (TM) is OCF.

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.

K862297THE D & C PAD-SAC

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.

↑