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)

POWERED SURGICAL INSTRUMENT ACCESSORY

K-Number: K930363 · 1994-01-07

Decision Date1994-01-07
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POWERED SURGICAL INSTRUMENT ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Intenn Engineering, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K930363. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERED SURGICAL INSTRUMENT ACCESSORY?

POWERED SURGICAL INSTRUMENT ACCESSORY is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Intenn Engineering, Inc.. The 510(k) number is K930363.

When did POWERED SURGICAL INSTRUMENT ACCESSORY receive FDA 510(k) clearance?

POWERED SURGICAL INSTRUMENT ACCESSORY received FDA 510(k) clearance on 1994-01-07, under 510(k) number K930363.

Who is the listed applicant for POWERED SURGICAL INSTRUMENT ACCESSORY?

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

What is the FDA product code for POWERED SURGICAL INSTRUMENT ACCESSORY?

The FDA product code for POWERED SURGICAL INSTRUMENT ACCESSORY is HWE.

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.

Related Devices (Code: HWE)

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.

↑