Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM

K-Number: K003164 · 2001-01-08

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date2001-01-08
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 2001-01-08 under 510(k) number K003164. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM?

TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM is a medical device that received FDA 510(k) clearance on 2001-01-08. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K003164.

When did TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM receive FDA 510(k) clearance?

TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM received FDA 510(k) clearance on 2001-01-08, under 510(k) number K003164.

Who is the listed applicant for TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM?

The FDA product code for TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM is HET.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Richard Wolf Medical Instruments Corp. 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.

K151282core nova Complete Operating Room EndoscopyK130423THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2K120898KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CAK090776MEGAPULSE LASER SYSTEM AND FIBERSK080617POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES

View all 142 devices →

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , 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.

↑