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FDA 510(k)

(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE

K-Number: K870355 · 1987-04-01

ApplicantCook Urological, Inc.
Decision Date1987-04-01
Product CodeOCZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1987-04-01 under 510(k) number K870355. 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 (URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE?

(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE is a medical device that received FDA 510(k) clearance on 1987-04-01. The listed applicant is Cook Urological, Inc.. The 510(k) number is K870355.

When did (URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE receive FDA 510(k) clearance?

(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE received FDA 510(k) clearance on 1987-04-01, under 510(k) number K870355.

Who is the listed applicant for (URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE?

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

What is the FDA product code for (URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE?

The FDA product code for (URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE is OCZ.

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Other records listing Cook Urological, Inc. as applicant

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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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