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FDA 510(k)

BLADE, SCALPEL & BLADE, HANDEL

K-Number: K954536 · 1995-11-29

ApplicantAccess Surgical Intl., Inc.
Decision Date1995-11-29
Product CodeOCZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BLADE, SCALPEL & BLADE, HANDEL 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 1995-11-29 under 510(k) number K954536. The device is classified under product code OCZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLADE, SCALPEL & BLADE, HANDEL?

BLADE, SCALPEL & BLADE, HANDEL is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Access Surgical Intl., Inc.. The 510(k) number is K954536.

When did BLADE, SCALPEL & BLADE, HANDEL receive FDA 510(k) clearance?

BLADE, SCALPEL & BLADE, HANDEL received FDA 510(k) clearance on 1995-11-29, under 510(k) number K954536.

Who is the listed applicant for BLADE, SCALPEL & BLADE, HANDEL?

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 BLADE, SCALPEL & BLADE, HANDEL?

The FDA product code for BLADE, SCALPEL & BLADE, HANDEL is OCZ.

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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.

K953376ACCESS POINTK945545ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTSK944974ACCESS POINTK940587FLEX-I-PORTK933192ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.K922424ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM.

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Related Devices (Code: OCZ)

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.

K252800KARL STORZ Endoscopic Accessories for UrologyKarl Storz SE & CO. KGK242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)Envision EndoscopyK191900Single Use Grasping ForcepsZhejiang Chuangxiang Medical Technology Co., Ltd.K152802Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd.K120084ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.K103688G-PROX EZ ENDOSCOPIC GRASPERUsgi Medical

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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