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FDA 510(k)

URO MED NERVE STIMULATOR

K-Number: K970971 · 1997-10-27

ApplicantUromed Corp.
Decision Date1997-10-27
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

URO MED NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Uromed Corp.. It received FDA 510(k) clearance on 1997-10-27 under 510(k) number K970971. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URO MED NERVE STIMULATOR?

URO MED NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 1997-10-27. The listed applicant is Uromed Corp.. The 510(k) number is K970971.

When did URO MED NERVE STIMULATOR receive FDA 510(k) clearance?

URO MED NERVE STIMULATOR received FDA 510(k) clearance on 1997-10-27, under 510(k) number K970971.

Who is the listed applicant for URO MED NERVE STIMULATOR?

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

What is the FDA product code for URO MED NERVE STIMULATOR?

The FDA product code for URO MED NERVE STIMULATOR is ETN.

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Other records listing Uromed Corp. 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.

K010213MODIFICATION TO CAVERMAP SURGICAL AIDK010098MODIFICATION TO CAVERMAP SURGICAL AIDK000507CAVERMAP SURGICAL AIDK993436CAVERMAP SURGICAL AIDK982226UROMED BRACHYTHERAPHY IODINE-125 SOURCESK980717UROMED SLING KIT

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Related Devices (Code: ETN)

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.

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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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