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)

GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE

K-Number: K970619 · 1997-11-19

ApplicantWilson Greatbatch Technologies, Inc.
Decision Date1997-11-19
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Wilson Greatbatch Technologies, Inc.. It received FDA 510(k) clearance on 1997-11-19 under 510(k) number K970619. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE?

GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE is a medical device that received FDA 510(k) clearance on 1997-11-19. The listed applicant is Wilson Greatbatch Technologies, Inc.. The 510(k) number is K970619.

When did GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE receive FDA 510(k) clearance?

GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE received FDA 510(k) clearance on 1997-11-19, under 510(k) number K970619.

Who is the listed applicant for GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE?

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

What is the FDA product code for GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE?

The FDA product code for GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE is CCW.

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 Wilson Greatbatch Technologies, 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.

K971374GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPEK971377GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPEK972280GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPESK971781GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPESK971375GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPEK954649WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP

View all 9 devices →

Related Devices (Code: CCW)

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.

K191602APA Oxy BladeVenner Medical (Singapore) Pte, Ltd.K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLCK121378AIRTRAQ SP AIRTRAQ AVANTProdol Meditec , Ltd.K063477NOVAMED MRI CONDITIONAL LARYNGOSCOPE SETNovamed, LLCK062523TRU-MR LARYNGOSCOPE SETTruphatek International, Ltd.K062230MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002Minrad, Inc.

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.

↑