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FDA 510(k)

ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM

K-Number: K922425 · 1992-11-17

ApplicantAccess Surgical Intl., Inc.
Decision Date1992-11-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM is the device name listed in this FDA 510(k) record. The listed applicant is Access Surgical Intl., Inc.. It received FDA 510(k) clearance on 1992-11-17 under 510(k) number K922425. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM?

ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM is a medical device that received FDA 510(k) clearance on 1992-11-17. The listed applicant is Access Surgical Intl., Inc.. The 510(k) number is K922425.

When did ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM receive FDA 510(k) clearance?

ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM received FDA 510(k) clearance on 1992-11-17, under 510(k) number K922425.

Who is the listed applicant for ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM?

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

What is the FDA product code for ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM?

The FDA product code for ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM is GEI.

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Other records listing Access Surgical Intl., 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.

K954536BLADE, SCALPEL & BLADE, HANDELK953376ACCESS POINTK945545ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTSK944974ACCESS POINTK940587FLEX-I-PORTK933192ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.

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Related Devices (Code: GEI)

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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