FDA 510(k)

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device

K-Number: K161763 · 2016-11-22

Decision Date2016-11-22

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161763. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device?

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K161763.

When did Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device receive FDA 510(k) clearance?

Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161763.

Who is the listed applicant for Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device?

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

What is the FDA product code for Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device?

The FDA product code for Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device is HIH.

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: HIH)

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker Endoscopy K243382RZ Resectoscope SystemRz Medizintechnik GmbH

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.