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FDA 510(k)

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)

K-Number: K242923 · 2024-12-20

ApplicantEnvision Endoscopy
Decision Date2024-12-20
Product CodeOCZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is the device name listed in this FDA 510(k) record. The listed applicant is Envision Endoscopy. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242923. 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 SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Envision Endoscopy. The 510(k) number is K242923.

When did SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) receive FDA 510(k) clearance?

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242923.

Who is the listed applicant for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

The FDA 510(k) record lists Envision Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

The FDA product code for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is OCZ.

Other records listing Envision Endoscopy 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.

K243750SimpleStitch Suturing System

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. KGK191900Single Use Grasping ForcepsZhejiang Chuangxiang Medical Technology Co., Ltd.K152802Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd.

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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