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FDA 510(k)

FLEXIBLE ENDOSCOPIC SCISSORS

K-Number: K010412 · 2001-04-02

ApplicantTelemed Systems, Inc.
Decision Date2001-04-02
Product CodeOCZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE ENDOSCOPIC SCISSORS is the device name listed in this FDA 510(k) record. The listed applicant is Telemed Systems, Inc.. It received FDA 510(k) clearance on 2001-04-02 under 510(k) number K010412. 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 FLEXIBLE ENDOSCOPIC SCISSORS?

FLEXIBLE ENDOSCOPIC SCISSORS is a medical device that received FDA 510(k) clearance on 2001-04-02. The listed applicant is Telemed Systems, Inc.. The 510(k) number is K010412.

When did FLEXIBLE ENDOSCOPIC SCISSORS receive FDA 510(k) clearance?

FLEXIBLE ENDOSCOPIC SCISSORS received FDA 510(k) clearance on 2001-04-02, under 510(k) number K010412.

Who is the listed applicant for FLEXIBLE ENDOSCOPIC SCISSORS?

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

What is the FDA product code for FLEXIBLE ENDOSCOPIC SCISSORS?

The FDA product code for FLEXIBLE ENDOSCOPIC SCISSORS is OCZ.

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Other records listing Telemed Systems, 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.

K020379PPD BALLOON DILATATION CATHETERK013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONK9924025.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCHK992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATDK974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSARK974300TELEMED SYSTEMS RETRIEVAL BASKET

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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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