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FDA 510(k)

DISPOSABLE HEATED WIRE LOOPS 48 AND 72

K-Number: K860941 · 1986-04-02

Decision Date1986-04-02
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HEATED WIRE LOOPS 48 AND 72 is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1986-04-02 under 510(k) number K860941. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE HEATED WIRE LOOPS 48 AND 72?

DISPOSABLE HEATED WIRE LOOPS 48 AND 72 is a medical device that received FDA 510(k) clearance on 1986-04-02. The listed applicant is Intec Medical, Inc.. The 510(k) number is K860941.

When did DISPOSABLE HEATED WIRE LOOPS 48 AND 72 receive FDA 510(k) clearance?

DISPOSABLE HEATED WIRE LOOPS 48 AND 72 received FDA 510(k) clearance on 1986-04-02, under 510(k) number K860941.

Who is the listed applicant for DISPOSABLE HEATED WIRE LOOPS 48 AND 72?

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

What is the FDA product code for DISPOSABLE HEATED WIRE LOOPS 48 AND 72?

The FDA product code for DISPOSABLE HEATED WIRE LOOPS 48 AND 72 is BZE.

Related Clinical Trials

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.

Other records listing Intec Medical, 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.

View all 17 devices →

Related Devices (Code: BZE)

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.

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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